510(k) K150901

Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express by Edan Instruments, Inc. — Product Code HGM

K150901 is an FDA 510(k) premarket notification submitted by Edan Instruments, Inc. for the device "Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express". The FDA issued a decision of Substantially Equivalent on July 1, 2015. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Edan Instruments, Inc. has at least 10 other 510(k) clearances on record.