510(k) K260273

Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) by Shenzhen Urion Technology Co., Ltd. — Product Code DXN

K260273 is an FDA 510(k) premarket notification submitted by Shenzhen Urion Technology Co., Ltd. for the device "Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)". The FDA issued a decision of Substantially Equivalent on March 26, 2026. 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.