K222551 is an FDA 510(k) clearance for the Humask Pro Vision, Humask Pro Vision 3000. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Entreprise Premont, Inc. (Louiseville, CA). The FDA issued a Cleared decision on November 10, 2022, 79 days after receiving the submission on August 23, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K222551 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2022 |
| Decision Date | November 10, 2022 |
| Days to Decision | 79 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |