MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605— 510(k) K043006

Substantially Equivalent

Respironics, Inc.

FDA 510(k) clearance K043006 for MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605, Substantially Equivalent on 2005-02-11. Applicant: Respironics, Inc..

Clearance details

Applicant: Respironics, Inc.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2004-11-01
Decision date: 2005-02-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Murrysville, 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.