K253228
- 510(k) number
- K253228
- Device name
- YUWELL® Electronic Blood Pressure Monitor (YE650AR)
- Applicant
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2026-02-23
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K253228.pdf
Official FDA record: K253228
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.