K223835 is an FDA 510(k) clearance for the MA-40, MA-112. This device is classified as a Cleaner, Air, Medical Recirculating (Class II - Special Controls, product code FRF).
Submitted by Medify Air, LLC (Boca Raton, US). The FDA issued a Cleared decision on September 18, 2023, 270 days after receiving the submission on December 22, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5045.
| 510(k) Number | K223835 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2022 |
| Decision Date | September 18, 2023 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRF — Cleaner, Air, Medical Recirculating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5045 |