AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS— 510(k) K993833

Substantially Equivalent

Allegiance Healthcare Corp.

FDA 510(k) clearance K993833 for AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS, Substantially Equivalent on 1999-12-10. Applicant: Allegiance Healthcare Corp..

Clearance details

Applicant: Allegiance Healthcare Corp.
Product code: Code BZE
Advisory panel: Anesthesiology
Date received: 1999-11-12
Decision date: 1999-12-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Mcgraw Park, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BZE

product code BZE

Death: 4
Malfunction: 910
Other: 1
Total: 915

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.