FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS— 510(k) K121747

Name: FDA 510(k) clearance K121747
Creator: U.S. Food and Drug Administration
Published: 2013-03-14

Substantially Equivalent

Intersurgical Incorporated

FDA 510(k) clearance K121747 for FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS, Substantially Equivalent on 2013-03-14. Applicant: Intersurgical Incorporated. Device class: 2.

Clearance details

Applicant: Intersurgical Incorporated
Product code: Code BZD
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 2012-06-14
Decision date: 2013-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Liverpool, NY, US

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.