OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8— 510(k) K880044

Substantially Equivalent

Oxygen Enrichment Company, Ltd.

FDA 510(k) clearance K880044 for OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8, Substantially Equivalent on 1988-03-28. Applicant: Oxygen Enrichment Company, Ltd..

Clearance details

Applicant: Oxygen Enrichment Company, Ltd.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 1988-01-06
Decision date: 1988-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schenectady, 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.