AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER— 510(k) K080926

Name: FDA 510(k) clearance K080926
Creator: U.S. Food and Drug Administration
Published: 2008-08-12

Substantially Equivalent

Trudell Medical Intl.

FDA 510(k) clearance K080926 for AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER, Substantially Equivalent on 2008-08-12. Applicant: Trudell Medical Intl.. Device class: 2.

Clearance details

Applicant: Trudell Medical Intl.
Product code: Code CAF
Device class: Class 2
Regulation: 21 CFR 868.5630
Advisory panel: Anesthesiology
Date received: 2008-04-02
Decision date: 2008-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, CA

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.