K230379 is an FDA 510(k) clearance for the Portable (Ultrasonic) Nebulizer. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Dongguan Simzo Electronic Technology Co., Ltd. (Dongguan City, CN). The FDA issued a Cleared decision on November 27, 2023, 287 days after receiving the submission on February 13, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K230379 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2023 |
| Decision Date | November 27, 2023 |
| Days to Decision | 287 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 |