K223100 is an FDA 510(k) clearance for the Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14). This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on June 27, 2023, 270 days after receiving the submission on September 30, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K223100 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2022 |
| Decision Date | June 27, 2023 |
| Days to Decision | 270 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 |