PURITAN-BENNETT NASAL CPAP MASK— 510(k) K942246

Name: FDA 510(k) clearance K942246
Creator: U.S. Food and Drug Administration
Published: 1994-07-06

Substantially Equivalent

Puritan-Bennett

FDA 510(k) clearance K942246 for PURITAN-BENNETT NASAL CPAP MASK, Substantially Equivalent on 1994-07-06. Applicant: Puritan-Bennett. Device class: 2.

Clearance details

Applicant: Puritan-Bennett
Product code: Code BYE
Device class: Class 2
Regulation: 21 CFR 868.5965
Advisory panel: Anesthesiology
Date received: 1994-05-09
Decision date: 1994-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BYE

product code BYE

Death: 5
Total: 5

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.