510(k) K871082

FETAL CARE MONITOR ANTEPARTUM 1500 by Pie Data Medical BV — Product Code HGM

K871082 is an FDA 510(k) premarket notification submitted by Pie Data Medical BV for the device "FETAL CARE MONITOR ANTEPARTUM 1500". The FDA issued a decision of Substantially Equivalent on August 4, 1987. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Pie Data Medical BV has at least 4 other 510(k) clearances on record.