K252805
- 510(k) number
- K252805
- Device name
- YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
- Applicant
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. CN
- Product code
- DQA — Oximeter
- Decision date
- 2026-02-17
- Date received
- 2025-09-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K252805.pdf
Official FDA record: K252805
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.