QUIXIE NEBULIZER— 510(k) K112564

Substantially Equivalent

Odyssey Medical Technologies

FDA 510(k) clearance K112564 for QUIXIE NEBULIZER, Substantially Equivalent on 2011-11-23. Applicant: Odyssey Medical Technologies.

Clearance details

Applicant: Odyssey Medical Technologies
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2011-09-02
Decision date: 2011-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmichael, CA, US

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.