510(k) K241578

Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) by Shenzhen Bsx Technology Electronics Co., Ltd. — Product Code DXN

K241578 is an FDA 510(k) premarket notification submitted by Shenzhen Bsx Technology Electronics Co., Ltd. for the device "Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)". The FDA issued a decision of Substantially Equivalent on February 19, 2025. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Shenzhen Bsx Technology Electronics Co., Ltd. has at least 4 other 510(k) clearances on record.