SYSTEM ONE OXYGEN CONCENTRATOR— 510(k) K821393

Substantially Equivalent

Marathon

FDA 510(k) clearance K821393 for SYSTEM ONE OXYGEN CONCENTRATOR, Substantially Equivalent on 1982-08-10. Applicant: Marathon.

Clearance details

Applicant: Marathon
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 1982-05-11
Decision date: 1982-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.