K213169 is an FDA 510(k) clearance for the BPAP System. This device is classified as a Ventilator, Continuous, Non-life-supporting (Class II - Special Controls, product code MNS).
Submitted by BMC Medical Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on December 5, 2022, 433 days after receiving the submission on September 28, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K213169 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2021 |
| Decision Date | December 05, 2022 |
| Days to Decision | 433 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MNS - Ventilator, Continuous, Non-life-supporting |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |