AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006— 510(k) K991484

Substantially Equivalent

Allegiance Healthcare Corp.

FDA 510(k) clearance K991484 for AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006, Substantially Equivalent on 1999-05-13. Applicant: Allegiance Healthcare Corp..

Clearance details

Applicant: Allegiance Healthcare Corp.
Product code: Code BTT
Advisory panel: Anesthesiology
Date received: 1999-04-28
Decision date: 1999-05-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Mcgraw Park, IL, US

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Adverse events under product code BTT

product code BTT

Death: 60
Injury: 152
Malfunction: 7,232
Other: 2
Total: 7,446

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.