Portable Oxygen Concentrator, model: P2-E6— 510(k) K210371
Substantially EquivalentQingdao Kingon Medical Science and Technology Co., Ltd.
FDA 510(k) clearance K210371 for Portable Oxygen Concentrator, model: P2-E6, Substantially Equivalent on 2022-06-03. Applicant: Qingdao Kingon Medical Science and Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Qingdao Kingon Medical Science and Technology 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
- Qingdao Free Trade Zone, CN
Recent devices under product code CAW
view allMore clearances from Qingdao Kingon Medical Science and Technology 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.