SUREBREATH DOME, E-Z BREATHER— 510(k) K915158

Name: FDA 510(k) clearance K915158
Creator: U.S. Food and Drug Administration
Published: 1992-02-12

Substantially Equivalent

Ipax, Inc.

FDA 510(k) clearance K915158 for SUREBREATH DOME, E-Z BREATHER, Substantially Equivalent on 1992-02-12. Applicant: Ipax, Inc.. Device class: 1.

Clearance details

Applicant: Ipax, Inc.
Product code: Code GAD
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1991-11-14
Decision date: 1992-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GAD

product code GAD

Malfunction: 504
Total: 504

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.