The following data is part of a premarket notification filed by Molekule, Inc. with the FDA for Molekule Air Pro.
| Device ID | K211194 |
| 510k Number | K211194 |
| Device Name: | Molekule Air Pro |
| Classification | Purifier, Air, Ultraviolet, Medical |
| Applicant | Molekule, Inc. 1301 Folsom St. San Francisco, CA 94103 |
| Contact | Frank Bianco |
| Correspondent | Adrienne R. Lenz Hymann, Phelps, & McNamara, P.C. 700 Thirteenth Street, N.W., Suite 1200 Washington, DC 20005 |
| Product Code | FRA |
| CFR Regulation Number | 880.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-21 |
| Decision Date | 2021-08-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818701020353 | K211194 | 000 |