The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Datascope System 95.
| Device ID | K912629 |
| 510k Number | K912629 |
| Device Name: | DATASCOPE SYSTEM 95 |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | DATASCOPE CORP. 580 WINTERS AVE. P.O. BOX 5 Paramus, NJ 07653 |
| Contact | Michael Barile |
| Correspondent | Michael Barile DATASCOPE CORP. 580 WINTERS AVE. P.O. BOX 5 Paramus, NJ 07653 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-17 |
| Decision Date | 1992-03-11 |