K241007
- 510(k) number
- K241007
- Device name
- Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)
- Applicant
- Shenzhen Urion Technology Co., Ltd. CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2024-10-24
- Date received
- 2024-04-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.9 MB · U.S. public domain
Also available from FDA: K241007.pdf
Official FDA record: K241007
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.