510(k) Report

Devices descending from K082946

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

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