K254225
- 510(k) number
- K254225
- Device name
- Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)
- Applicant
- Shenzhen HanHan Technology Co., Ltd. CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2026-04-01
- Date received
- 2025-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K254225.pdf
Official FDA record: K254225
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.