MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS— 510(k) K000697

Substantially Equivalent

Allegiance Healthcare Corp.

FDA 510(k) clearance K000697 for MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS, Substantially Equivalent on 2000-03-30. Applicant: Allegiance Healthcare Corp..

Clearance details

Applicant: Allegiance Healthcare Corp.
Product code: Code BZE
Advisory panel: Anesthesiology
Date received: 2000-03-01
Decision date: 2000-03-30
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.