The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Multinex Monitor (modification).
| Device ID | K883254 |
| 510k Number | K883254 |
| Device Name: | MULTINEX MONITOR (MODIFICATION) |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | DATASCOPE CORP. WINTERS AVE. P.O. BOX 5 Paramus, NJ 07653 -0005 |
| Contact | Arthur Friedman |
| Correspondent | Arthur Friedman DATASCOPE CORP. WINTERS AVE. P.O. BOX 5 Paramus, NJ 07653 -0005 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-02 |
| Decision Date | 1988-09-12 |