Device Classification Name |
automated external defibrillators (non-wearable)
|
510(k) Number |
K072812 |
Device Name |
PHILIPS HEARTSTART SMARTPADS III |
Applicant |
PHILIPS MEDICAL SYSTEMS |
2301 FIFTH AVE., SUITE 200 |
SEATTLE,
WA
98121
|
|
Applicant Contact |
LARRY WALKER |
Correspondent |
PHILIPS MEDICAL SYSTEMS |
2301 FIFTH AVE., SUITE 200 |
SEATTLE,
WA
98121
|
|
Correspondent Contact |
LARRY WALKER |
Regulation Number | 870.5310
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/01/2007 |
Decision Date | 02/26/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|