Device Classification Name |
automated external defibrillators (non-wearable)
|
510(k) Number |
K970741 |
Device Name |
POWERHEART AECD |
Applicant |
CARDIAC SCIENCE, INC. |
1176 MAIN STREET, BLDG. C |
IRVINE,
CA
92614
|
|
Applicant Contact |
RAYMOND COHEN |
Correspondent |
CARDIAC SCIENCE, INC. |
1176 MAIN STREET, BLDG. C |
IRVINE,
CA
92614
|
|
Correspondent Contact |
RAYMOND COHEN |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 02/28/1997 |
Decision Date | 10/16/1997 |
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
|
|
|