510(k) K252669

Fetal Doppler U8-25, U9-25 by Zhongshan Xiaolan Town Senlan Electronic Factory — Product Code KNG

K252669 is an FDA 510(k) premarket notification submitted by Zhongshan Xiaolan Town Senlan Electronic Factory for the device "Fetal Doppler U8-25, U9-25". The FDA issued a decision of Substantially Equivalent on January 8, 2026. The device falls under product code KNG (Monitor, Ultrasonic, Fetal), a Class II device regulated under 21 CFR 884.2660.