INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)— 510(k) K132489

Substantially Equivalent

Inogen, Inc.

FDA 510(k) clearance K132489 for INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME), Substantially Equivalent on 2014-06-20. Applicant: Inogen, Inc..

Clearance details

Applicant: Inogen, Inc.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2013-08-08
Decision date: 2014-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, 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.