510(k) K211041

Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W1681 by Shenzhen Yuezhongxing Technology Co., Ltd. — Product Code DXN

K211041 is an FDA 510(k) premarket notification submitted by Shenzhen Yuezhongxing Technology Co., Ltd. for the device "Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W1681". The FDA issued a decision of Substantially Equivalent on August 30, 2021. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Shenzhen Yuezhongxing Technology Co., Ltd. has at least 2 other 510(k) clearances on record.