K221957 is an FDA 510(k) clearance for the Savewo ClassicMASK. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Savewo Limited (Hong Kong, CN). The FDA issued a Cleared decision on September 2, 2022, 59 days after receiving the submission on July 5, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K221957 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2022 |
| Decision Date | September 02, 2022 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| 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 |