510(k) K162092

Evolv Model BP7000 Upper Arm Blood Pressure Monitor by Omron Healthcare, Inc. — Product Code DXN

K162092 is an FDA 510(k) premarket notification submitted by Omron Healthcare, Inc. for the device "Evolv Model BP7000 Upper Arm Blood Pressure Monitor". The FDA issued a decision of Substantially Equivalent on November 22, 2016. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Omron Healthcare, Inc. has at least 10 other 510(k) clearances on record.