510(k) K241007

Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) by Shenzhen Urion Technology Co., Ltd. — Product Code DXN

K241007 is an FDA 510(k) premarket notification submitted by Shenzhen Urion Technology Co., Ltd. for the device "Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)". The FDA issued a decision of Substantially Equivalent on October 24, 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 Urion Technology Co., Ltd. has at least 7 other 510(k) clearances on record.