Device Classification Name |
automated external defibrillators (non-wearable)
|
510(k) Number |
K130153 |
Device Name |
HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST |
Applicant |
PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD |
ANDOVER,
MA
01810
|
|
Applicant Contact |
MARK PUOPOLO |
Correspondent |
PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
MARK PUOPOLO |
Regulation Number | 870.5310
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/22/2013 |
Decision Date | 03/12/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|