510(k) K241882

Fetal & Maternal Monitor (F15A, F15A Air) by Edan Instruments, Inc. — Product Code HGM

K241882 is an FDA 510(k) premarket notification submitted by Edan Instruments, Inc. for the device "Fetal & Maternal Monitor (F15A, F15A Air)". The FDA issued a decision of Substantially Equivalent on August 27, 2025. 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.