510(k) Report

Devices descending from K974352

11 later devices reach Cardioview 3000 Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090895Ekg-Plus II SoftwareBionet Co., Ltd.20090—
+1K083749CARDIOVIEW32 Review ModuleQrs Diagnostic, LLC20099—
+2K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd.20143—
+2K102378Vectraplexecg System with VectraplexamiVectracor, Inc.20112—
+2K103427Mobileecg SystemMemtec Corp.20111—
+3K173952Universal SmartECGVectracor, Inc.20181—
+3K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+3K142349TM eCloud ECG Analysis SystemTelemed Solutions, Inc.20150—
+4K232035ImpalaAliveCor, Inc.20240—
+4K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+5K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007