AF541 EE Full Face Mask— 510(k) K150639

Name: FDA 510(k) clearance K150639
Creator: U.S. Food and Drug Administration
Published: 2015-09-18

Substantially Equivalent

Respironics, Inc.

FDA 510(k) clearance K150639 for AF541 EE Full Face Mask, Substantially Equivalent on 2015-09-18. Applicant: Respironics, Inc.. Device class: 2.

Clearance details

Applicant: Respironics, Inc.
Product code: Code BZD
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 2015-03-11
Decision date: 2015-09-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Murrysville, PA, 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.