K252769
- 510(k) number
- K252769
- Device name
- Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116)
- Applicant
- Shenzhen Finicare Co., Ltd. CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2025-10-02
- Date received
- 2025-09-02
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252769.pdf
Official FDA record: K252769
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.