Device Classification Name |
automated external defibrillators (non-wearable)
|
510(k) Number |
K130684 |
Device Name |
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR |
Applicant |
PHILIPS MEDICAL SYSTEMS |
22100 BOTHELL EVERETT HIGHWAY |
BOTHELL,
WA
98041 -3003
|
|
Applicant Contact |
NANCY BURKE |
Correspondent |
PHILIPS MEDICAL SYSTEMS |
22100 BOTHELL EVERETT HIGHWAY |
BOTHELL,
WA
98041 -3003
|
|
Correspondent Contact |
NANCY BURKE |
Regulation Number | 870.5310
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/13/2013 |
Decision Date | 10/18/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|