510(k) K010920

TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING by Medical Cables, Inc. — Product Code HEL

K010920 is an FDA 510(k) premarket notification submitted by Medical Cables, Inc. for the device "TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING". The FDA issued a decision of Substantially Equivalent on June 22, 2001. The device falls under product code HEL (Monitor, Heart Rate, Fetal, Ultrasonic), a Class II device regulated under 21 CFR 884.2660. Medical Cables, Inc. has at least 2 other 510(k) clearances on record.