510(k) K254225

Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL) by Shenzhen HanHan Technology Co., Ltd. — Product Code DXN

K254225 is an FDA 510(k) premarket notification submitted by Shenzhen HanHan Technology Co., Ltd. for the device "Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)". The FDA issued a decision of Substantially Equivalent on April 1, 2026. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130.