K254048
- 510(k) number
- K254048
- Device name
- Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)
- Applicant
- Shenzhen Urion Technology Co., Ltd. CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2026-05-14
- Date received
- 2025-12-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.8 MB · U.S. public domain
Also available from FDA: K254048.pdf
Official FDA record: K254048
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.