K941336 is an FDA 510(k) clearance for the COMBO MASK. This device is classified as a Mask, Oxygen, Non-rebreathing (Class I - General Controls, product code KGB).
Submitted by Gam Industries, Inc. (Petersburg, US). The FDA issued a Cleared decision on September 9, 1994, 172 days after receiving the submission on March 21, 1994.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5570.
| 510(k) Number | K941336 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 1994 |
| Decision Date | September 09, 1994 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | KGB — Mask, Oxygen, Non-rebreathing |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5570 |