510(k) K173367— MC 300* Nebulizer

Substantially Equivalent

Trudell Medical International

Clearance details

Applicant: Trudell Medical International
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2017-10-26
Decision date: 2018-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, CA

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.