NASAL MASK, NASAL MASK, FULL FACE MASK— 510(k) K133009

Name: FDA 510(k) clearance K133009
Creator: U.S. Food and Drug Administration
Published: 2014-04-23

Substantially Equivalent

BMC Medical Co., Ltd.

FDA 510(k) clearance K133009 for NASAL MASK, NASAL MASK, FULL FACE MASK, Substantially Equivalent on 2014-04-23. Applicant: BMC Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: BMC Medical Co., Ltd.
Product code: Code BZD
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 2013-09-25
Decision date: 2014-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

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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.