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[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
[CITE: 21CFR874.1100]
 See Related Information on 874.1100 in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 874 -- EAR, NOSE, AND THROAT DEVICES

Subpart B--Diagnostic Devices
Sec. 874.1100 Earphone cushion for audiometric testing.

(a)Identification. An earphone cushion for audiometric testing is a device that is used to cover an audiometer earphone during audiometric testing to provide an acoustic coupling (sound connection path) between the audiometer earphone and the patient's ear.

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 874.9.

[51 FR 40389, Nov. 9, 1986; 52 FR 18495, May 15, 1987, as amended at 52 FR 32111, Aug. 25, 1987; 65 FR 2315, Jan. 14, 2000]

Database Updated April 1, 2008

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