K232797 is an FDA 510(k) clearance for the Hygenix. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Shenzhen Hygenix Industrial Co., Ltd. (Longgang District, CN). The FDA issued a Cleared decision on December 11, 2023, 90 days after receiving the submission on September 12, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K232797 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2023 |
| Decision Date | December 11, 2023 |
| Days to Decision | 90 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 |