Device Classification Name |
System, Balloon, Intra-Aortic And Control
|
510(k) Number |
K942454 |
Device Name |
DATASCOPE 95 AND 97 IAB PUMP CONSOLE |
Applicant |
DATASCOPE CORP. |
3 FIR CT. |
P.O. BOX 3100 |
OAKLAND,
NJ
07436
|
|
Applicant Contact |
DIANE M ARPINO |
Correspondent |
DATASCOPE CORP. |
3 FIR CT. |
P.O. BOX 3100 |
OAKLAND,
NJ
07436
|
|
Correspondent Contact |
DIANE M ARPINO |
Regulation Number | 870.3535
|
Classification Product Code |
|
Date Received | 05/23/1994 |
Decision Date | 02/24/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|