Device Classification Name |
Automated External Defibrillators (Non-Wearable)
|
510(k) Number |
K020715 |
FOIA Releasable 510(k) |
K020715
|
Device Name |
PHILIPS M5066A AND M5068A |
Applicant |
PHILIPS MEDICAL SYSTEMS |
2301 FIFTH AVE., SUITE 200 |
SEATTLE,
WA
98121
|
|
Applicant Contact |
TAMARA YOUNT |
Correspondent |
PHILIPS MEDICAL SYSTEMS |
2301 FIFTH AVE., SUITE 200 |
SEATTLE,
WA
98121
|
|
Correspondent Contact |
TAMARA YOUNT |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 03/05/2002 |
Decision Date | 11/08/2002 |
Decision |
SE SUBJECT TO TRACKING REG
(ST) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|