510(k) K191673

Upper Arm Blood Pressure Monitor by Famidoc Technology Company Limited — Product Code DXN

K191673 is an FDA 510(k) premarket notification submitted by Famidoc Technology Company Limited for the device "Upper Arm Blood Pressure Monitor". The FDA issued a decision of Substantially Equivalent on November 27, 2019. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Famidoc Technology Company Limited has at least 2 other 510(k) clearances on record.