Device Classification Name |
device, counter-pulsating, external
|
510(k) Number |
K872034 |
Device Name |
CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM |
Applicant |
CARDIOMEDICS, INC. |
19401 S. VERMONT AVENUE (B- |
100) |
TORRANCE,
CA
90502
|
|
Applicant Contact |
Joseph J Schwoebel |
Correspondent |
CARDIOMEDICS, INC. |
19401 S. VERMONT AVENUE (B- |
100) |
TORRANCE,
CA
90502
|
|
Correspondent Contact |
Joseph J Schwoebel |
Regulation Number | 870.5225
|
Classification Product Code |
|
Date Received | 05/27/1987 |
Decision Date | 09/18/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|