K251607
- 510(k) number
- K251607
- Device name
- Oxygen Concentrator (J5A)
- Applicant
- Foshan Kycare Medical Equipment Co., Ltd. CN
- Product code
- CAW — Generator, Oxygen, Portable
- Decision date
- 2025-11-21
- Date received
- 2025-05-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251607.pdf
Official FDA record: K251607
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.