GCE Zen-O Portable Oxygen Concentrator— 510(k) K162433

Substantially Equivalent

Oxus, Inc.

FDA 510(k) clearance K162433 for GCE Zen-O Portable Oxygen Concentrator, Substantially Equivalent on 2017-05-24. Applicant: Oxus, Inc..

Clearance details

Applicant: Oxus, Inc.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2016-08-31
Decision date: 2017-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auburn Hills, MI, US

Download summary PDF View on FDA.gov ↗

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.