K222702 is an FDA 510(k) clearance for the RGS. This device is classified as a Purifier, Air, Ultraviolet, Medical (Class II - Special Controls, product code FRA).
Submitted by Genesis Air, Inc. (Lubbock, US). The FDA issued a Cleared decision on June 2, 2023, 268 days after receiving the submission on September 7, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6500.
| 510(k) Number | K222702 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2022 |
| Decision Date | June 02, 2023 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRA - Purifier, Air, Ultraviolet, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6500 |