K211194 is an FDA 510(k) clearance for the Molekule Air Pro. This device is classified as a Purifier, Air, Ultraviolet, Medical (Class II - Special Controls, product code FRA).
Submitted by Molekule, Inc. (San Francisco, US). The FDA issued a Cleared decision on August 20, 2021, 121 days after receiving the submission on April 21, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6500.
| 510(k) Number | K211194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 2021 |
| Decision Date | August 20, 2021 |
| Days to Decision | 121 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 |