CRITERION II & IIA OXYGEN CONCENTRATORS— 510(k) K871603

Substantially Equivalent

Timeter Instrument Corp.

FDA 510(k) clearance K871603 for CRITERION II & IIA OXYGEN CONCENTRATORS, Substantially Equivalent on 1987-08-13. Applicant: Timeter Instrument Corp..

Clearance details

Applicant: Timeter Instrument Corp.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 1987-04-24
Decision date: 1987-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lancaster, PA, 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.