Drive DeVilbiss iGo 2 Portable Oxygen Concentrator— 510(k) K172648

Substantially Equivalent

Devilbiss Healthcare, LLC

FDA 510(k) clearance K172648 for Drive DeVilbiss iGo 2 Portable Oxygen Concentrator, Substantially Equivalent on 2018-03-23. Applicant: Devilbiss Healthcare, LLC.

Clearance details

Applicant: Devilbiss Healthcare, LLC
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2017-09-01
Decision date: 2018-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, PA, 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.