Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)— 510(k) K163464

Substantially Equivalent

Bmc Medical., Ltd.

FDA 510(k) clearance K163464 for Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2), Substantially Equivalent on 2017-09-05. Applicant: Bmc Medical., Ltd..

Clearance details

Applicant: Bmc Medical., Ltd.
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2016-12-09
Decision date: 2017-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haidian, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.