Brand Name | CODEMASTER XL |
Type of Device | PORTABLE DEFIB/MON |
Baseline Brand Name | CODEMASTER 100 |
Baseline Generic Name | PORTABLE DEFIB/MONITOR |
Baseline Catalogue Number | M2475B |
Baseline Model Number | M2475B |
Baseline Device Family | CODEMASTER 100 DEFIB/MONITOR |
Baseline Device 510(K) Number | K954957 |
Baseline Device PMA Number | |
Baseline Preamendment? |
No
|
Transitional? |
No
|
510(K) Exempt? |
No
|
Shelf Life(Months) | NA |
Date First Marketed | 05/22/1995 |
Manufacturer (Section F) |
AGILENT TECHNOLOGIES, INC. |
3000 minuteman rd. |
andover MA 01810 1099 |
|
Manufacturer (Section D) |
AGILENT TECHNOLOGIES, INC. |
3000 minuteman rd. |
andover MA 01810 1099 |
|
Manufacturer Contact |
sharon
downs
|
3000 minuteman road |
andover
, MA 01810-1099 |
(978)
659
-3643
|
|
Device Event Key | 292957 |
MDR Report Key | 302675 |
Event Key | 284403 |
Report Number | 1218950-2000-00189 |
Device Sequence Number | 1 |
Product Code | LDD |
Report Source |
Manufacturer
|
Source Type |
User facility,Company Representative
|
Reporter Occupation |
UNKNOWN
|
Type of Report
| Initial |
Report Date |
02/04/2000 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 10/27/2000 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
UNKNOWN
|
Device MODEL Number | M2475B |
Device Catalogue Number | M2475B |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 02/16/2000 |
Is The Reporter A Health Professional? |
No Answer Provided
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 02/04/2000 |
Was Device Evaluated By Manufacturer? |
Yes
|
Is The Device Single Use? |
No
|
Is the Device an Implant? |
No
|
Is this an Explanted Device? |
No Answer Provided
|
Type of Device Usage |
Reuse
|