OXYGEN CONCENTRATOR— 510(k) K781300

Substantially Equivalent

Bendix Instruments & Life Support Div

FDA 510(k) clearance K781300 for OXYGEN CONCENTRATOR, Substantially Equivalent on 1978-10-16. Applicant: Bendix Instruments & Life Support Div.

Clearance details

Applicant: Bendix Instruments & Life Support Div
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 1978-07-28
Decision date: 1978-10-16
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.