ANESTHESIA BREATHING CIRCUITS— 510(k) K801191

Substantially Equivalent

Airlife, Inc.

FDA 510(k) clearance K801191 for ANESTHESIA BREATHING CIRCUITS, Substantially Equivalent on 1980-05-28. Applicant: Airlife, Inc..

Clearance details

Applicant: Airlife, Inc.
Product code: Code CAI
Advisory panel: Anesthesiology
Date received: 1980-05-19
Decision date: 1980-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code CAI

product code CAI

Malfunction: 869
Other: 1
Total: 870

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.