K062263 is an FDA 510(k) clearance for the OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22. 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 February 23, 2007, 203 days after receiving the submission on August 4, 2006.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K062263 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2006 |
| Decision Date | February 23, 2007 |
| Days to Decision | 203 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 |