K884879 is an FDA 510(k) clearance for the CENTURION(TM) MIXER. This device is classified as a Gas-machine, Anesthesia (Class II - Special Controls, product code BSZ).
Submitted by Matrix Medica, Inc. (Orchard Park, US). The FDA issued a Cleared decision on February 9, 1989, 80 days after receiving the submission on November 21, 1988.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5160.
| 510(k) Number | K884879 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 1988 |
| Decision Date | February 09, 1989 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BSZ — Gas-machine, Anesthesia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5160 |