510(k) K220113

Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112) by Shenzhen Finicare Co., Ltd. — Product Code DXN

K220113 is an FDA 510(k) premarket notification submitted by Shenzhen Finicare Co., Ltd. for the device "Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112)". The FDA issued a decision of Substantially Equivalent on May 31, 2022. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Shenzhen Finicare Co., Ltd. has at least 5 other 510(k) clearances on record.