510(k) K202228

Omron Model BP7900 Blood Pressure Monitor + EKG by Omron Healthcare, Inc. — Product Code DXN

K202228 is an FDA 510(k) premarket notification submitted by Omron Healthcare, Inc. for the device "Omron Model BP7900 Blood Pressure Monitor + EKG". The FDA issued a decision of Substantially Equivalent on April 1, 2021. 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.