K243468 is an FDA 510(k) clearance for the Compressor Nebulizer (NB-1100). This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Joytech Healthcare Co. , Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on July 2, 2025, 236 days after receiving the submission on November 8, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K243468 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2024 |
| Decision Date | July 02, 2025 |
| Days to Decision | 236 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 |