K212395 is an FDA 510(k) clearance for the Nebulizer. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Shenzhen Homed Medical Device Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 25, 2022, 235 days after receiving the submission on August 2, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K212395 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2021 |
| Decision Date | March 25, 2022 |
| Days to Decision | 235 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 |