510(k) Report

Devices descending from K102140

3 later devices reach Fetal Monitors, Models F2 and F3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+1K141194FM-3000 Fetal MonitorAdvanced Instrumentations, Inc.20140—
+2K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—