The following data is part of a premarket notification filed by Datascope Corp. with the FDA for 3000 Physiological Monitor.
| Device ID | K880301 |
| 510k Number | K880301 |
| Device Name: | 3000 PHYSIOLOGICAL MONITOR |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | DATASCOPE CORP. 580 WINTERS AVE. P.O. BOX 5 Paramus, NJ 07653 |
| Contact | Arthur Friedman |
| Correspondent | Arthur Friedman DATASCOPE CORP. 580 WINTERS AVE. P.O. BOX 5 Paramus, NJ 07653 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-25 |
| Decision Date | 1988-08-19 |