K201397 is an FDA 510(k) clearance for the Ultrasonic Mesh Nebulizer. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Shenzhen Ivankaca Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 14, 2021, 382 days after receiving the submission on May 28, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K201397 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 2020 |
| Decision Date | June 14, 2021 |
| Days to Decision | 382 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 |