510(k) K182166

Wrist Blood Pressure Monitor Model BP4350 by Omron Healthcare, Inc. — Product Code DXN

K182166 is an FDA 510(k) premarket notification submitted by Omron Healthcare, Inc. for the device "Wrist Blood Pressure Monitor Model BP4350". The FDA issued a decision of Substantially Equivalent on November 8, 2018. 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.