YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B— 510(k) K083559
Substantially EquivalentJiangsu Yuyue Medical Equipment & Supply Co., Ltd.
FDA 510(k) clearance K083559 for YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B, Substantially Equivalent on 2009-09-04. Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd..
Clearance details
- Applicant
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Product code
- Code CAW
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- 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, through . 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.