510(k) Report

Devices descending from K090367

13 later devices reach SE-601 Series Electrocardiograph through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130207Spacelabs Healthcare CardioexpressSpacelabs Healthcare, Ltd.20130—
+1K112135Ecg-6 Series ElectrocardiographAdvanced Instrumentations, Inc.20110—
+1K093869SE-601 Series ElectrocardiographEdan Instruments, Inc.201010—
+2K131503SE-601 Series ElectrocardiographEdan Instruments, Inc.20149—
+3K160876PC ECGEdan Instruments, Inc.20178—
+4K171942ElectrocardiographEdan Instruments, Inc.20183—
+4K170995ElectrocardiographEdan Instruments, Inc.20173—
+5K212278ElectrocardiographEdan Instruments, Inc.20222—
+5K220362LE-12CHCaf Medical Solutions, Inc.20220—
+5K210140electrocardiograph: SE-1202Edan Instruments, Inc.20211—
+6K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.20260—
+6K222902Electrocardiograph: SE-1200 Pro and SE-1201 ProEdan Instruments, Inc.20231—
+7K232210X-trodes System MX-Trodes20240—