510(k) K163045

Omron HEM-6400T-Z Wrist Blood Pressure Monitor by Omron Healthcare, Inc. — Product Code DXN

K163045 is an FDA 510(k) premarket notification submitted by Omron Healthcare, Inc. for the device "Omron HEM-6400T-Z Wrist Blood Pressure Monitor". The FDA issued a decision of Substantially Equivalent on February 21, 2017. 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.