K223328 is an FDA 510(k) clearance for the Purgo. This device is classified as a Purifier, Air, Ultraviolet, Medical (Class II - Special Controls, product code FRA).
Submitted by Aeroclean Technologies, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on November 30, 2022, 30 days after receiving the submission on October 31, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6500.
| 510(k) Number | K223328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2022 |
| Decision Date | November 30, 2022 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |