K211772 is an FDA 510(k) clearance for the PMW01 Procedure Mask Level 1. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Defender Safety, Inc. (Plainview, US). The FDA issued a Cleared decision on December 6, 2021, 181 days after receiving the submission on June 8, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K211772 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2021 |
| Decision Date | December 06, 2021 |
| Days to Decision | 181 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |