510(k) K231367

Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) by Shenzhen Finicare Co., Ltd. — Product Code DXN

K231367 is an FDA 510(k) premarket notification submitted by Shenzhen Finicare Co., Ltd. for the device "Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)". The FDA issued a decision of Substantially Equivalent on September 18, 2023. 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.