510(k) K182526

Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) by Vcomin Technology Limited — Product Code KNG

K182526 is an FDA 510(k) premarket notification submitted by Vcomin Technology Limited for the device "Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)". The FDA issued a decision of Substantially Equivalent on May 29, 2019. The device falls under product code KNG (Monitor, Ultrasonic, Fetal), a Class II device regulated under 21 CFR 884.2660.