K083559

Substantially Equivalent

YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B

Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Product code: CAW
Advisory panel: Anesthesiology
Date received: 2008-12-02
Decision date: 2009-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Potomac, MD, US

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.