K182906 is an FDA 510(k) clearance for the Portable Mesh Nebulizer. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Feellife Health, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on September 27, 2020, 711 days after receiving the submission on October 17, 2018.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K182906 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 2018 |
| Decision Date | September 27, 2020 |
| Days to Decision | 711 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CAF - Nebulizer (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |