510(k) K233799

Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R) by Shenzhen Yuezhongxing Technology Co., Ltd. — Product Code DXN

K233799 is an FDA 510(k) premarket notification submitted by Shenzhen Yuezhongxing Technology Co., Ltd. for the device "Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R)". The FDA issued a decision of Substantially Equivalent on March 15, 2024. 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.