Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A— 510(k) K213825
Substantially EquivalentJiangsu Yuyue Medical Equipment & Supply Co., Ltd.
FDA 510(k) clearance K213825 for Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A, Substantially Equivalent on 2023-04-28. Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Product code
- Code CAW
- Device class
- Class 2
- Regulation
- 21 CFR 868.5440
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danyang, CN
Recent devices under product code CAW
view allMore clearances from Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
view allAdverse 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.