510(k) K043075

TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING by Tenacore Holdings, Inc. — Product Code HGM

K043075 is an FDA 510(k) premarket notification submitted by Tenacore Holdings, Inc. for the device "TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING". The FDA issued a decision of Substantially Equivalent on August 18, 2005. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Tenacore Holdings, Inc. has at least 3 other 510(k) clearances on record.