QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER— 510(k) K112824

Substantially Equivalent

Quality Life Technologies Co;Ltd

FDA 510(k) clearance K112824 for QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER, Substantially Equivalent on 2012-06-21. Applicant: Quality Life Technologies Co;Ltd.

Clearance details

Applicant: Quality Life Technologies Co;Ltd
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2011-09-28
Decision date: 2012-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dover, DE, 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.