510(k) K230642

Electronic Blood Pressure Monitor by Dongguan Kangweile Electronic Technology Co., Ltd. — Product Code DXN

K230642 is an FDA 510(k) premarket notification submitted by Dongguan Kangweile Electronic Technology Co., Ltd. for the device "Electronic Blood Pressure Monitor". The FDA issued a decision of Substantially Equivalent on August 11, 2023. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Dongguan Kangweile Electronic Technology Co., Ltd. has at least 1 other 510(k) clearance on record.