The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Datascope Multinex Ii.
| Device ID | K926451 |
| 510k Number | K926451 |
| Device Name: | DATASCOPE MULTINEX II |
| Classification | Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) |
| 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 | CBQ |
| CFR Regulation Number | 868.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-24 |
| Decision Date | 1993-08-25 |