K253133
- 510(k) number
- K253133
- Device name
- Wrist Blood Pressure Monitor (BPM-W1VL)
- Applicant
- Shenzhen Imdk Medical Technology Co., Ltd. CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2026-02-13
- Date received
- 2025-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K253133.pdf
Official FDA record: K253133
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.