Oxygen Concentrator— 510(k) K230969
Substantially EquivalentJiangsu Jumao X-Care Medical Equipment Co., Ltd.
FDA 510(k) clearance K230969 for Oxygen Concentrator, Substantially Equivalent on 2023-11-09. Applicant: Jiangsu Jumao X-Care Medical Equipment Co., Ltd..
Clearance details
- Applicant
- Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
- Product code
- Code CAW
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danyang, CN
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.