K230602 is an FDA 510(k) clearance for the Hudson RCI® TurboMist™ Nebulizer System. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Medline Industries, LP (Northfiled, US). The FDA issued a Cleared decision on October 31, 2023, 242 days after receiving the submission on March 3, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K230602 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2023 |
| Decision Date | October 31, 2023 |
| Days to Decision | 242 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 |