510(k) Report

Devices descending from K062677

26 later devices reach Eli 350 Electrocardiograph through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082946Mortara Eli 350 ElectrocardiographMortara Instrument, Inc.200825—
+2K142105Eli 380 ElectrocardiographMortara Instrument, Inc.201443
+2K131929Surveyor Central StationMortara Instrument, Inc.20136—
+2K102206Eli 10 Electrocardiograph Model Eli 10Mortara Instrument, Inc.201101
+2K101403Eli 250 ElectrocardiographMortara Instrument, Inc.201021
+2K101115Eli 150 Electrocardiograph Model Eli 150Mortara Instrument, Inc.201001
+2K093339Eli PC ElectrocardiographMortara Instrument, Inc.201061
+2K092663Eli 350 ElectrocardiographMortara Instrument, Inc.200901
+3K173830MAC VU360 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.201834
+3K160840ECG100+, ECG200+Cardioline S.P.A20160—
+3K141811Mortara Monitoring Waveform ViewerMortara Instrument, Inc.20141—
+3K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+3K122073Eli 280 ElectrocardiographMortara Instrument, Inc.201202
+3K120865Rscribe ElectrocardiographMortara Instrument, Inc.201221
+3K110065Spaulding IQ ElectrocardiographSpaulding Clinical Research, LLC20112—
+4K260250QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)QT Medical, Inc.20260—
+4K222586Mural Clinical ViewerGe Medical Systems Information Technologies, Inc.20220—
+4K203786MAC 7 - Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.20212—
+4K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+4K160746CARDIOLINE touchECGCardioline S.P.A20160—
+4K150564Spaulding Electrocardiograph 2100iQSpaulding Clinical Research, LLC20151—
+5K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.20260—
+5K221321MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.202201
+5K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+5K163607ECG Acquisition SystemsVales & Hills Biomedical Tech., Ltd.20170—
+6K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007