K230702
- 510(k) number
- K230702
- Device name
- Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)
- Applicant
- Qingdao Kingon Medical Science and Technology Co., Ltd. CN
- Product code
- CAW — Generator, Oxygen, Portable
- Decision date
- 2023-10-18
- Date received
- 2023-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K230702.pdf
Official FDA record: K230702
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.