K926451 is an FDA 510(k) clearance for the DATASCOPE MULTINEX II. This device is classified as a Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) (Class II - Special Controls, product code CBQ).
Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on August 25, 1993, 244 days after receiving the submission on December 24, 1992.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1500.
| 510(k) Number | K926451 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 1992 |
| Decision Date | August 25, 1993 |
| Days to Decision | 244 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CBQ - Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1500 |