K251581
- 510(k) number
- K251581
- Device name
- Wearable Ambulatory Blood Pressure Monitor (WBP-02A)
- Applicant
- Shenzhen Hingmed Medical Instrument Co., Ltd. CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2026-02-13
- Date received
- 2025-05-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251581.pdf
Official FDA record: K251581
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.