510(k) Report

Devices descending from K972649

19 later devices reach Cardiocall Cardiac Event Recorder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063609River- 1 Electrocardiograph (Ecg) Recorder and TransmitterShl Telemedicine International, Ltd.200717—
+1K991211Eventstation Ecg Trans-Telephonic Receiving SystemReynolds Medical, Ltd.19990—
+2K091579Foresee HomeNotal Vision, Ltd.20094—
+2K080047Cardiosen'cShl Telemedicine International, Ltd.200811—
+3K121738Myvisiontrack (TM)Vital Art and Science Incorporated20133—
+3K113514SmartheartShl Telemedicine International, Ltd.201210—
+4K180157QT ECGQT Medical, Inc.20182—
+4K143211myVision Track Model 005Vital Art and Science Incorporated20152—
+4K142476Master Caution Device MCDHealthwatch, Ltd.20156—
+5K220795QT ECGQT Medical, Inc.20221—
+5K173248CardioskinBioserenity Sas20180—
+5K180895AlleyeOculocare Medical AG20181—
+5K161431SimplECGNanowear, Inc.20165—
+6K233521QT Ecg (QTERD100)QT Medical, Inc.20230—
+6K203594EyeCTesterNeuro-Eye Diagnostic Systems, LLC20220—
+6K201669SimpleSENSENanowear, Inc.20203—
+7K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.20250—
+7K212160SimpleSENSE PlatformNanowear, Inc.20211—
+8K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—