K202171 is an FDA 510(k) clearance for the Pulmogine Vibrating Mesh Nebulizer. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Hcmed Innovations Co., Ltd. (Taipei City, TW). The FDA issued a Cleared decision on July 1, 2021, 332 days after receiving the submission on August 3, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K202171 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2020 |
| Decision Date | July 01, 2021 |
| Days to Decision | 332 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 |