Device Classification Name |
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
|
510(k) Number |
K850170 |
Device Name |
HEART AID MODEL 97 |
Applicant |
CARDIAC RESUCITATOR CORP. |
25117 S.W. PKWY. |
WILSONVILLE,
OR
97070
|
|
Applicant Contact |
JEREMIAH F O'BRIEN |
Correspondent |
CARDIAC RESUCITATOR CORP. |
25117 S.W. PKWY. |
WILSONVILLE,
OR
97070
|
|
Correspondent Contact |
JEREMIAH F O'BRIEN |
Regulation Number | 870.5550
|
Classification Product Code |
|
Date Received | 01/16/1985 |
Decision Date | 02/14/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|