CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615— 510(k) K982243

Substantially Equivalent

Canogen International , Ltd.

FDA 510(k) clearance K982243 for CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615, Substantially Equivalent on 1998-11-19. Applicant: Canogen International , Ltd..

Clearance details

Applicant: Canogen International , Ltd.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 1998-06-25
Decision date: 1998-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laurel, MD, 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.