510(k) K244007

ArteVu by Cardio Ring Technologies, Inc. Taiwan Branch — Product Code DXN

K244007 is an FDA 510(k) premarket notification submitted by Cardio Ring Technologies, Inc. Taiwan Branch for the device "ArteVu". The FDA issued a decision of Substantially Equivalent on July 30, 2025. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130.