AEROECLIPSE II BREATH ACTUATED NEBULIZER— 510(k) K053605

Substantially Equivalent

Trudell Medical Intl.

FDA 510(k) clearance K053605 for AEROECLIPSE II BREATH ACTUATED NEBULIZER, Substantially Equivalent on 2006-02-27. Applicant: Trudell Medical Intl..

Clearance details

Applicant: Trudell Medical Intl.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2005-12-27
Decision date: 2006-02-27
Decision: Substantially Equivalent
Clearance type: Special
Location: London, CA

Download summary PDF View on FDA.gov ↗

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.