K942021 is an FDA 510(k) clearance for the MOUTH TO MOUTH BREATHER. This device is classified as a Valve, Non-rebreathing (Class II - Special Controls, product code CBP).
Submitted by Gam Industries, Inc. (Petersburg, US). The FDA issued a Cleared decision on June 22, 1994, 57 days after receiving the submission on April 26, 1994.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5870.
| 510(k) Number | K942021 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 1994 |
| Decision Date | June 22, 1994 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBP — Valve, Non-rebreathing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5870 |