K210288 is an FDA 510(k) clearance for the Disposable Manual Resuscitator. This device is classified as a Ventilator, Emergency, Manual (resuscitator) (Class II - Special Controls, product code BTM).
Submitted by Xiamen Compower Medical Tech. Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on August 26, 2021, 205 days after receiving the submission on February 2, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5915.
| 510(k) Number | K210288 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2021 |
| Decision Date | August 26, 2021 |
| Days to Decision | 205 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTM - Ventilator, Emergency, Manual (resuscitator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5915 |