Device Classification Name |
Automated External Defibrillators (Non-Wearable)
|
510(k) Number |
K031187 |
Device Name |
HEARTSTART MRX, MODEL M3535A |
Applicant |
PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. |
ANDOVER,
MA
01810 -1099
|
|
Applicant Contact |
PETER OHANIAN |
Correspondent |
PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. |
ANDOVER,
MA
01810 -1099
|
|
Correspondent Contact |
PETER OHANIAN |
Regulation Number | 870.5310
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/15/2003 |
Decision Date | 08/27/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|