BPAP System— 510(k) K213169

Substantially Equivalent

BMC Medical Co., Ltd.

FDA 510(k) clearance K213169 for BPAP System, Substantially Equivalent on 2022-12-05. Applicant: BMC Medical Co., Ltd..

Clearance details

Applicant: BMC Medical Co., Ltd.
Product code: Code MNS
Advisory panel: Anesthesiology
Date received: 2021-09-28
Decision date: 2022-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code MNS

product code MNS

Death: 344
Injury: 1,160
Malfunction: 8,068
Total: 9,572

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.