K081516 is an FDA 510(k) clearance for the MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT. This device is classified as a Valve, Non-rebreathing (Class II - Special Controls, product code CBP).
Submitted by Medsource International, LLC (Mound, US). The FDA issued a Cleared decision on August 26, 2008, 88 days after receiving the submission on May 30, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5870.
| 510(k) Number | K081516 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2008 |
| Decision Date | August 26, 2008 |
| Days to Decision | 88 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 |