HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009— 510(k) K012037

Substantially Equivalent

Airsep Corp.

FDA 510(k) clearance K012037 for HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009, Substantially Equivalent on 2002-01-17. Applicant: Airsep Corp..

Clearance details

Applicant: Airsep Corp.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2001-06-29
Decision date: 2002-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, 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.