Device Classification Name |
automated external defibrillators (non-wearable)
|
510(k) Number |
K013425 |
Device Name |
HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A |
Applicant |
PHILIPS MEDICAL SYSTEMS |
2401 FOURTH AVE., SUITE 500 |
SEATTLE,
WA
98121
|
|
Applicant Contact |
TAMARA YOUNT |
Correspondent |
PHILIPS MEDICAL SYSTEMS |
2401 FOURTH AVE., SUITE 500 |
SEATTLE,
WA
98121
|
|
Correspondent Contact |
TAMARA YOUNT |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 10/16/2001 |
Decision Date | 01/14/2002 |
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
|
|
|