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Title 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION,
DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 868--ANESTHESIOLOGY DEVICES
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 | 868.1 | Scope. |
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| 868.3 | Effective dates of requirement for premarket approval. |
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| 868.9 | Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
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| 868.1030 | Manual algesimeter. |
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| 868.1040 | Powered algesimeter. |
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| 868.1075 | Argon gas analyzer. |
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| 868.1100 | Arterial blood sampling kit. |
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| 868.1120 | Indwelling blood oxyhemoglobin concentration analyzer. |
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| 868.1150 | Indwelling blood carbon dioxide partial pressure (PCO2) analyzer. |
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| 868.1170 | Indwelling blood hydrogen ion concentration (pH) analyzer. |
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| 868.1200 | Indwelling blood oxygen partial pressure (PO2) analyzer. |
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| 868.1400 | Carbon dioxide gas analyzer. |
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| 868.1430 | Carbon monoxide gas analyzer. |
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| 868.1500 | Enflurane gas analyzer. |
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| 868.1575 | Gas collection vessel. |
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| 868.1620 | Halothane gas analyzer. |
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| 868.1640 | Helium gas analyzer. |
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| 868.1670 | Neon gas analyzer. |
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| 868.1690 | Nitrogen gas analyzer. |
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| 868.1700 | Nitrous oxide gas analyzer. |
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| 868.1720 | Oxygen gas analyzer. |
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| 868.1730 | Oxygen uptake computer. |
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| 868.1750 | Pressure plethysmograph. |
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| 868.1760 | Volume plethysmograph. |
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| 868.1780 | Inspiratory airway pressure meter. |
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| 868.1800 | Rhinoanemometer. |
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| 868.1840 | Diagnostic spirometer. |
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| 868.1850 | Monitoring spirometer. |
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| 868.1860 | Peak-flow meter for spirometry. |
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| 868.1870 | Gas volume calibrator. |
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| 868.1880 | Pulmonary-function data calculator. |
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| 868.1890 | Predictive pulmonary-function value calculator. |
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| 868.1900 | Diagnostic pulmonary-function interpretation calculator. |
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| 868.1910 | Esophageal stethoscope. |
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| 868.1920 | Esophageal stethoscope with electrical conductors. |
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| 868.1930 | Stethoscope head. |
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| 868.1965 | Switching valve (ploss). |
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| 868.1975 | Water vapor analyzer. |
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| 868.2025 | Ultrasonic air embolism monitor. |
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| 868.2300 | Bourdon gauge flowmeter. |
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| 868.2320 | Uncompensated thorpe tube flowmeter. |
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| 868.2340 | Compensated thorpe tube flowmeter. |
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| 868.2350 | Gas calibration flowmeter. |
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| 868.2375 | Breathing frequency monitor. |
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| 868.2450 | Lung water monitor. |
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| 868.2480 | Cutaneous carbon dioxide (PcCO2) monitor. |
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| 868.2500 | Cutaneous oxygen monitor. |
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| 868.2550 | Pneumotachometer. |
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| 868.2600 | Airway pressure monitor. |
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| 868.2610 | Gas pressure gauge. |
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| 868.2620 | Gas pressure calibrator. |
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| 868.2700 | Pressure regulator. |
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| 868.2775 | Electrical peripheral nerve stimulator. |
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| 868.2875 | Differential pressure transducer. |
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| 868.2885 | Gas flow transducer. |
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| 868.2900 | Gas pressure transducer. |
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| 868.5090 | Emergency airway needle. |
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| 868.5100 | Nasopharyngeal airway. |
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| 868.5110 | Oropharyngeal airway. |
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| 868.5120 | Anesthesia conduction catheter. |
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| 868.5130 | Anesthesia conduction filter. |
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| 868.5140 | Anesthesia conduction kit. |
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| 868.5150 | Anesthesia conduction needle. |
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| 868.5160 | Gas machine for anesthesia or analgesia. |
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| 868.5170 | Laryngotracheal topical anesthesia applicator. |
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| 868.5180 | Rocking bed. |
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| 868.5220 | Blow bottle. |
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| 868.5240 | Anesthesia breathing circuit. |
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| 868.5250 | Breathing circuit circulator. |
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| 868.5260 | Breathing circuit bacterial filter. |
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| 868.5270 | Breathing system heater. |
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| 868.5280 | Breathing tube support. |
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| 868.5300 | Carbon dioxide absorbent. |
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| 868.5310 | Carbon dioxide absorber. |
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| 868.5320 | Reservoir bag. |
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| 868.5330 | Breathing gas mixer. |
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| 868.5340 | Nasal oxygen cannula. |
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| 868.5350 | Nasal oxygen catheter. |
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| 868.5365 | Posture chair for cardiac or pulmonary treatment. |
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| 868.5375 | Heat and moisture condenser (artificial nose). |
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| 868.5400 | Electroanesthesia apparatus. |
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| 868.5420 | Ether hook. |
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| 868.5430 | Gas-scavenging apparatus. |
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| 868.5440 | Portable oxygen generator. |
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| 868.5450 | Respiratory gas humidifier. |
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| 868.5460 | Therapeutic humidifier for home use. |
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| 868.5470 | Hyperbaric chamber. |
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| 868.5530 | Flexible laryngoscope. |
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| 868.5540 | Rigid laryngoscope. |
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| 868.5550 | Anesthetic gas mask. |
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| 868.5560 | Gas mask head strap. |
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| 868.5570 | Nonrebreathing mask. |
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| 868.5580 | Oxygen mask. |
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| 868.5590 | Scavenging mask. |
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| 868.5600 | Venturi mask. |
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| 868.5610 | Membrane lung for long-term pulmonary support. |
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| 868.5620 | Breathing mouthpiece. |
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| 868.5630 | Nebulizer. |
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| 868.5640 | Medicinal nonventilatory nebulizer (atomizer). |
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| 868.5650 | Esophageal obturator. |
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| 868.5655 | Portable liquid oxygen unit. |
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| 868.5665 | Powered percussor. |
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| 868.5675 | Rebreathing device. |
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| 868.5690 | Incentive spirometer. |
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| 868.5700 | Nonpowered oxygen tent. |
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| 868.5710 | Electrically powered oxygen tent. |
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| 868.5720 | Bronchial tube. |
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| 868.5730 | Tracheal tube. |
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| 868.5740 | Tracheal/bronchial differential ventilation tube. |
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| 868.5750 | Inflatable tracheal tube cuff. |
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| 868.5760 | Cuff spreader. |
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| 868.5770 | Tracheal tube fixation device. |
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| 868.5780 | Tube introduction forceps. |
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| 868.5790 | Tracheal tube stylet. |
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| 868.5795 | Tracheal tube cleaning brush. |
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| 868.5800 | Tracheostomy tube and tube cuff. |
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| 868.5810 | Airway connector. |
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| 868.5820 | Dental protector. |
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| 868.5830 | Autotransfusion apparatus. |
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| 868.5860 | Pressure tubing and accessories. |
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| 868.5870 | Nonrebreathing valve. |
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| 868.5880 | Anesthetic vaporizer. |
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| 868.5895 | Continuous ventilator. |
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| 868.5905 | Noncontinuous ventilator (IPPB). |
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| 868.5915 | Manual emergency ventilator. |
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| 868.5925 | Powered emergency ventilator. |
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| 868.5935 | External negative pressure ventilator. |
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| 868.5955 | Intermittent mandatory ventilation attachment. |
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| 868.5965 | Positive end expiratory pressure breathing attachment. |
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| 868.5975 | Ventilator tubing. |
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| 868.5995 | Tee drain (water trap). |
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| 868.6100 | Anesthetic cabinet, table, or tray. |
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| 868.6175 | Cardiopulmonary emergency cart. |
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| 868.6225 | Nose clip. |
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| 868.6250 | Portable air compressor. |
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| 868.6400 | Calibration gas. |
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| 868.6700 | Anesthesia stool. |
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| 868.6810 | Tracheobronchial suction catheter. |
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| 868.6820 | Patient position support. |
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| 868.6885 | Medical gas yoke assembly. |
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