LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000— 510(k) K072688

Substantially Equivalent

International Biophysics Corp.

FDA 510(k) clearance K072688 for LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000, Substantially Equivalent on 2008-01-11. Applicant: International Biophysics Corp..

Clearance details

Applicant: International Biophysics Corp.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2007-09-24
Decision date: 2008-01-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Austin, TX, 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.