510(k) K173042

Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 by Edan Instruments, Inc. — Product Code HGM

K173042 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; Fetal Monitor: Models F2, F3". The FDA issued a decision of Substantially Equivalent on August 30, 2018. 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.