510(k) K040819

TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834 by American I.V. Products, Inc. — Product Code HGM

K040819 is an FDA 510(k) premarket notification submitted by American I.V. Products, Inc. for the device "TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834". The FDA issued a decision of Substantially Equivalent on August 16, 2004. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. American I.V. Products, Inc. has at least 6 other 510(k) clearances on record.