510(k) Report

Devices descending from K955559

11 later devices reach Corometrics Fetal Movement Detection Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991739Corometrics 120 Series Maternal/Fetal MonitorGeneral Electric Medical Systems Information Techn199910—
+2K100797Fetal Maternal Monitor Model F9 Express and ExpressEdan Instruments, Inc.20105—
+2K082602Fetal & Maternal Monitor, Model F6, F9Edan Instruments, Inc.20086—
+2K032252Model 120 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies20032—
+3K150901Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 ExpressEdan Instruments, Inc.201521
+3K131941Fetal MonitorsGuangdong Biolight Meditech Co., Ltd.20140—
+3K112317FM-9000 Plus Fetal and Maternal MonitorAdvanced Instrumentations, Inc.20110—
+3K050583Model 250 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies20051—
+4K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+4K072976Model 250CX Series Maternal/Fetal MonitorGE Healthcare20070—
+5K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—