K883254 is an FDA 510(k) clearance for the MULTINEX MONITOR (MODIFICATION). This device is classified as a Analyzer, Gas, Oxygen, Gaseous-phase (Class II - Special Controls, product code CCL).
Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on September 12, 1988, 41 days after receiving the submission on August 2, 1988.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1720.
| 510(k) Number | K883254 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 1988 |
| Decision Date | September 12, 1988 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | - |
| Product Code | CCL - Analyzer, Gas, Oxygen, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1720 |