510(k) Report

Devices descending from K131503

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160876PC ECGEdan Instruments, Inc.20178—
+2K171942ElectrocardiographEdan Instruments, Inc.20183—
+2K170995ElectrocardiographEdan Instruments, Inc.20173—
+3K212278ElectrocardiographEdan Instruments, Inc.20222—
+3K220362LE-12CHCaf Medical Solutions, Inc.20220—
+3K210140electrocardiograph: SE-1202Edan Instruments, Inc.20211—
+4K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.20260—
+4K222902Electrocardiograph: SE-1200 Pro and SE-1201 ProEdan Instruments, Inc.20231—
+5K232210X-trodes System MX-Trodes20240—