ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM— 510(k) K132205

Substantially Equivalent

Inova Labs, Inc.

FDA 510(k) clearance K132205 for ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM, Substantially Equivalent on 2014-06-06. Applicant: Inova Labs, Inc..

Clearance details

Applicant: Inova Labs, Inc.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2013-07-16
Decision date: 2014-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasant Hill, CA, 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.