510(k) Report

Devices descending from K984504

17 later devices reach Nihon Kohden Ecg-9110K and Ecg-9130K Cardiofax Q and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072217Ecg-1250A Series Cardiofax S and Ecg-1350A Series Cardiofax MNihon Kohden America, Inc.200716—
+2K173226CardiMax ElectrocardiographFukuda Denshi USA, Inc.20180—
+2K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc.20170—
+2K090367SE-601 Series ElectrocardiographEdan Instruments, Inc.2009131
+3K130207Spacelabs Healthcare CardioexpressSpacelabs Healthcare, Ltd.20130—
+3K112135Ecg-6 Series ElectrocardiographAdvanced Instrumentations, Inc.20110—
+3K093869SE-601 Series ElectrocardiographEdan Instruments, Inc.201010—
+4K131503SE-601 Series ElectrocardiographEdan Instruments, Inc.20149—
+5K160876PC ECGEdan Instruments, Inc.20178—
+6K171942ElectrocardiographEdan Instruments, Inc.20183—
+6K170995ElectrocardiographEdan Instruments, Inc.20173—
+7K212278ElectrocardiographEdan Instruments, Inc.20222—
+7K220362LE-12CHCaf Medical Solutions, Inc.20220—
+7K210140electrocardiograph: SE-1202Edan Instruments, Inc.20211—
+8K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.20260—
+8K222902Electrocardiograph: SE-1200 Pro and SE-1201 ProEdan Instruments, Inc.20231—
+9K232210X-trodes System MX-Trodes20240—