510(k) K992811

TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING by Epic Medical Equipment Services, Inc. — Product Code HFM

K992811 is an FDA 510(k) premarket notification submitted by Epic Medical Equipment Services, Inc. for the device "TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING". The FDA issued a decision of Substantially Equivalent on January 18, 2000. The device falls under product code HFM (Monitor, Uterine Contraction, External (For Use In Clinic)), a Class II device regulated under 21 CFR 884.2720. Epic Medical Equipment Services, Inc. has at least 10 other 510(k) clearances on record.