Device Classification Name |
system, balloon, intra-aortic and control
|
510(k) Number |
K912629 |
Device Name |
DATASCOPE SYSTEM 95 |
Applicant |
DATASCOPE CORP. |
580 WINTERS AVE. |
P.O. BOX 5 |
PARAMUS,
NJ
07653
|
|
Applicant Contact |
MICHAEL BARILE |
Correspondent |
DATASCOPE CORP. |
580 WINTERS AVE. |
P.O. BOX 5 |
PARAMUS,
NJ
07653
|
|
Correspondent Contact |
MICHAEL BARILE |
Regulation Number | 870.3535
|
Classification Product Code |
|
Date Received | 06/17/1991 |
Decision Date | 03/11/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|