K250625
- 510(k) number
- K250625
- Device name
- Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))
- Applicant
- Nanjing Yinuoji Medical Technology Co., Ltd. CN
- Product code
- CAW — Generator, Oxygen, Portable
- Decision date
- 2025-08-27
- Date received
- 2025-03-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250625.pdf
Official FDA record: K250625
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.