C.P.A.P. VALVE AND C.P.P.A. KIT— 510(k) K895360

Name: FDA 510(k) clearance K895360
Creator: U.S. Food and Drug Administration
Published: 1989-11-15

Substantially Equivalent

Ballard Medical Products

FDA 510(k) clearance K895360 for C.P.A.P. VALVE AND C.P.P.A. KIT, Substantially Equivalent on 1989-11-15. Applicant: Ballard Medical Products. Device class: 2.

Clearance details

Applicant: Ballard Medical Products
Product code: Code BYE
Device class: Class 2
Regulation: 21 CFR 868.5965
Advisory panel: Anesthesiology
Date received: 1989-08-28
Decision date: 1989-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Midvale, UT, 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.