K120785 is an FDA 510(k) clearance for the OMNI 3 OXYGEN SYSTEM. This device is classified as a Generator, Oxygen, Portable (Class II - Special Controls, product code CAW).
Submitted by Caire, Inc. (San Diego, US). The FDA issued a Cleared decision on October 25, 2012, 224 days after receiving the submission on March 15, 2012.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K120785 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 2012 |
| Decision Date | October 25, 2012 |
| Days to Decision | 224 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAW — Generator, Oxygen, Portable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5440 |