AIRCARE 300— 510(k) K830324

Substantially Equivalent

Med.Com

FDA 510(k) clearance K830324 for AIRCARE 300, Substantially Equivalent on 1983-03-10. Applicant: Med.Com.

Clearance details

Applicant: Med.Com
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 1983-02-01
Decision date: 1983-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code CAW

product code CAW

Death: 204
Injury: 573
Malfunction: 1,400
Other: 6
Total: 2,183

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.