510(k) K222926

Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683 by Shenzhen Yuezhongxing Technology Co., Ltd. — Product Code DXN

K222926 is an FDA 510(k) premarket notification submitted by Shenzhen Yuezhongxing Technology Co., Ltd. for the device "Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683". The FDA issued a decision of Substantially Equivalent on May 5, 2023. 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.