510(k) K232815

Wrist Blood Pressure Monitor by Zhuhai Yueja Medical Device Technology Co., Ltd. — Product Code DXN

K232815 is an FDA 510(k) premarket notification submitted by Zhuhai Yueja Medical Device Technology Co., Ltd. for the device "Wrist Blood Pressure Monitor". The FDA issued a decision of Substantially Equivalent on December 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. Zhuhai Yueja Medical Device Technology Co., Ltd. has at least 2 other 510(k) clearances on record.