Device Classification Name |
pacemaker, cardiac, external transcutaneous (non-invasive)
|
510(k) Number |
K871569 |
Device Name |
MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR |
Applicant |
CARDIAC RESUCITATOR CORP. |
12244 S.W. GARDEN PLACE |
PORTLAND,
OR
97223
|
|
Applicant Contact |
JOHN L KARPOWICZ |
Correspondent |
CARDIAC RESUCITATOR CORP. |
12244 S.W. GARDEN PLACE |
PORTLAND,
OR
97223
|
|
Correspondent Contact |
JOHN L KARPOWICZ |
Regulation Number | 870.5550
|
Classification Product Code |
|
Date Received | 04/24/1987 |
Decision Date | 06/08/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|