Device Classification Name |
Compressor, Cardiac, External
|
510(k) Number |
K011046 |
Device Name |
AUTOPULSE, MODEL 100 |
Applicant |
REVIVANT CORP. |
775 PALOMAR |
SUNNYVALE,
CA
94085
|
|
Applicant Contact |
BOB KATZ |
Correspondent |
REVIVANT CORP. |
775 PALOMAR |
SUNNYVALE,
CA
94085
|
|
Correspondent Contact |
BOB KATZ |
Regulation Number | 870.5200
|
Classification Product Code |
|
Date Received | 04/06/2001 |
Decision Date | 10/25/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|