K833748 is an FDA 510(k) clearance for the RESCUE VALVE. This device is classified as a Valve, Non-rebreathing (Class II - Special Controls, product code CBP).
Submitted by Respironics, Inc. (Monroeville, US). The FDA issued a Cleared decision on December 8, 1983, 43 days after receiving the submission on October 26, 1983.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5870.
| 510(k) Number | K833748 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 1983 |
| Decision Date | December 08, 1983 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CBP — Valve, Non-rebreathing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5870 |