K201220 is an FDA 510(k) clearance for the Aerus Medical Guardian,model F170A. This device is classified as a Purifier, Air, Ultraviolet, Medical (Class II - Special Controls, product code FRA).
Submitted by Aerus Medical, LLC (Dallas, US). The FDA issued a Cleared decision on June 17, 2020, 42 days after receiving the submission on May 6, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6500.
| 510(k) Number | K201220 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2020 |
| Decision Date | June 17, 2020 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRA - Purifier, Air, Ultraviolet, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6500 |