510(k) K171865

F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring by Farus, LLC — Product Code HGM

K171865 is an FDA 510(k) premarket notification submitted by Farus, LLC for the device "F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring". The FDA issued a decision of Substantially Equivalent on August 24, 2017. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740.