510(k) K040392

TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING by American I.V. Products, Inc. — Product Code HFM

K040392 is an FDA 510(k) premarket notification submitted by American I.V. Products, Inc. for the device "TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING". The FDA issued a decision of Substantially Equivalent on September 14, 2004. 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. American I.V. Products, Inc. has at least 6 other 510(k) clearances on record.