510(k) Report

Devices descending from K040903

12 later devices reach Cadence, Models 2001 and 2002 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082369Cadence, Cadence Dual, Cadence II Fetal MonitorEdan Instruments, Inc.20084—
+1K073221Cadence IIEdan Instruments, Inc.200711—
+2K112187FM-1000 Plus Fetal MonitorAdvanced Instrumentations, Inc.20110—
+2K102140Fetal Monitors, Models F2 and F3Edan Instruments, Inc.201131
+2K082602Fetal & Maternal Monitor, Model F6, F9Edan Instruments, Inc.20086—
+3K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+3K141194FM-3000 Fetal MonitorAdvanced Instrumentations, Inc.20140—
+3K100797Fetal Maternal Monitor Model F9 Express and ExpressEdan Instruments, Inc.20105—
+4K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+4K150901Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 ExpressEdan Instruments, Inc.201521
+4K131941Fetal MonitorsGuangdong Biolight Meditech Co., Ltd.20140—
+4K112317FM-9000 Plus Fetal and Maternal MonitorAdvanced Instrumentations, Inc.20110—