K152197 is an FDA 510(k) clearance for the Skypro, SP01 Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Skypro Medical Supplies Company (Hong Kong, CN). The FDA issued a Cleared decision on August 26, 2016, 387 days after receiving the submission on August 5, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K152197 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2015 |
| Decision Date | August 26, 2016 |
| Days to Decision | 387 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 |