K110860 is an FDA 510(k) clearance for the COMP A-I-R. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Omron Healthcare, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on September 2, 2011, 157 days after receiving the submission on March 29, 2011.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K110860 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2011 |
| Decision Date | September 02, 2011 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAF — Nebulizer (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |