| 510(k) Number |
K860164 |
| Device Name |
2500 PRINTER |
| Applicant |
| Datascope Corp. |
| 580 Winters Ave. |
| P.O. Box 5 |
|
Paramus,
NJ
07653
|
|
| Applicant Contact |
ARTHUR FRIEDMAN |
| Correspondent |
| Datascope Corp. |
| 580 Winters Ave. |
| P.O. Box 5 |
|
Paramus,
NJ
07653
|
|
| Correspondent Contact |
ARTHUR FRIEDMAN |
| Date Received | 01/17/1986 |
| Decision Date | 06/05/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|