510(k) Report

Devices descending from K101264

16 later devices reach Tempus IC Professional Patient Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130773Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.201361
+1K113105Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd.20118—
+2K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+2K152124Tempus IC2Remote Diagnostics Technologies, Ltd.20157—
+2K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+2K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+2K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd.20143—
+3K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+3K152645Dictum HealthDictum Health, Inc.20166—
+4K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+4K170798Dictum HealthDictum Health, Inc.20175—
+5K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+6K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+7K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+7K240901StethophoneSparrow Acoustics, Inc.20241—
+8K252595Stethophone ProSparrow Acoustics, Inc.20250—