The following data is part of a premarket notification filed by Datascope Corp. with the FDA for System 90 And System 90t.
| Device ID | K913847 |
| 510k Number | K913847 |
| Device Name: | SYSTEM 90 AND SYSTEM 90T |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | DATASCOPE CORP. 14 PHILIPS PKWY. Montvale, NJ 07645 |
| Contact | Arthur Friedman |
| Correspondent | Arthur Friedman DATASCOPE CORP. 14 PHILIPS PKWY. Montvale, NJ 07645 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-27 |
| Decision Date | 1992-03-11 |