510(k) K052190

FETAL MONITOR, MODELS BT-300 AND BT-200 by Bistos Co., Ltd. — Product Code HGM

K052190 is an FDA 510(k) premarket notification submitted by Bistos Co., Ltd. for the device "FETAL MONITOR, MODELS BT-300 AND BT-200". The FDA issued a decision of Substantially Equivalent on October 4, 2005. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Bistos Co., Ltd. has at least 10 other 510(k) clearances on record.