Device Classification Name |
Automated External Defibrillators (Non-Wearable)
|
510(k) Number |
K021453 |
Device Name |
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A |
Applicant |
PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. |
ANDOVER,
MA
01810
|
|
Applicant Contact |
RICHARD J PETERSEN |
Correspondent |
PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
RICHARD J PETERSEN |
Regulation Number | 870.5310
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/06/2002 |
Decision Date | 07/03/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|