Device Classification Name |
compressor, cardiac, external
|
510(k) Number |
K040453 |
Device Name |
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 |
Applicant |
REVIVANT CORP. |
775 PALOMAR AVE. |
SUNNYVALE,
CA
94085
|
|
Applicant Contact |
BOB H KATZ |
Correspondent |
REVIVANT CORP. |
775 PALOMAR AVE. |
SUNNYVALE,
CA
94085
|
|
Correspondent Contact |
BOB H KATZ |
Regulation Number | 870.5200
|
Classification Product Code |
|
Date Received | 02/23/2004 |
Decision Date | 03/11/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|