Device Classification Name |
automated external defibrillators (non-wearable)
|
510(k) Number |
K122758 |
Device Name |
POWERHEART G5 AED |
Applicant |
CARDIAC SCIENCE CORPORATION |
N7 W22025 Johnson Dr |
-- |
Waukesha,
WI
53186
|
|
Applicant Contact |
KATHLEEN ROBERTS |
Correspondent |
CARDIAC SCIENCE CORPORATION |
N7 W22025 Johnson Dr |
-- |
Waukesha,
WI
53186
|
|
Correspondent Contact |
KATHLEEN ROBERTS |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 09/10/2012 |
Decision Date | 02/12/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|