K192285 is an FDA 510(k) clearance for the CPR Face Shield. This device is classified as a Valve, Non-rebreathing (Class II - Special Controls, product code CBP).
Submitted by Firstar Healthcare Company Limited (Guangzhou) (Guangzhou, CN). The FDA issued a Cleared decision on November 25, 2020, 461 days after receiving the submission on August 22, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5870.
| 510(k) Number | K192285 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2019 |
| Decision Date | November 25, 2020 |
| Days to Decision | 461 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CBP - Valve, Non-rebreathing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5870 |