510(k) K955931

MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION) by Advanced Medical Systems, Inc. — Product Code HGM

K955931 is an FDA 510(k) premarket notification submitted by Advanced Medical Systems, Inc. for the device "MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)". The FDA issued a decision of Substantially Equivalent on August 14, 1996. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Advanced Medical Systems, Inc. has at least 9 other 510(k) clearances on record.