K241578
- 510(k) number
- K241578
- Device name
- Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)
- Applicant
- Shenzhen Bsx Technology Electronics Co., Ltd. CN
- Product code
- DXN — System, Measurement, Blood-Pressure, Non-Invasive
- Decision date
- 2025-02-19
- Date received
- 2024-06-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K241578.pdf
Official FDA record: K241578
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.