510(k) Report

Devices descending from K043380

71 later devices reach Monebo Automatic Arrhythmia Detection Software Library, Version 1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062282Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0Monebo Technologies, Inc.200770—
+2K200036AI-ECG TrackerShenzhen Carewell Electronics Co., Ltd.20200—
+2K182093ZOLL ECG Analysis SoftwareZoll Manufacturing Corporation20190—
+2K180234physiQ Heart Rhythm ModulePhysiq, Inc.20187—
+2K170568CardioLogs ECG Analysis PlatformCardiologs Technologies201726—
+2K142827Visi Mobile Monitoring System, Visi Mobile Chest SensorSotera Wireless, Inc.20150—
+2K142693ZywieAI Software LibraryZywie, Inc.20150—
+2K122632Guava IICardiocomm Solutions, Inc.20142—
+2K103706The Core (Cardiac Outpatient Realtime Ecg) MonitorApplied Cardiac Systems, Inc.20111—
+2K091075Zeus (Zio Ecg Utilization Service) SystemiRhythm Technologies, Inc.200932—
+3K251218SafeBeat Rx AppSafeBeat Rx, Inc.20260—
+3K212112Cardiologs Holter PlatformCardiologs Technologies20217—
+3K210543IM007Implicity, Inc.20211—
+3K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+3K183322physIQ Heart Rhythm and Respiratory ModulePhysiq, Inc.20191—
+3K181823KardiaAIAliveCor, Inc.20196—
+3K182344RhythmAnalyticsBiofourmis Singapore Pte., Ltd.20197—
+3K162571Bioflux SoftwareBiotricity, Inc.20161—
+3K142352CardiacLinxRoss Medical Technology, Inc.20150—
+3K142681ZEUS (ZIO ECG Utilization Service) SystemiRhythm Technologies, Inc.201431—
+4K252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC20260—
+4K253463ILR ECG Analyzer (IM007)Implicity, Inc.20260—
+4K250569Cardiologs Holter PlatformPhilips France Commercial20250—
+4K243252ZBPro DiagnosticZbeats, Inc.20251—
+4K241197DeepRhythmAIMedicalgorithmics S.A.20243—
+4K232161DeepRhythm PlatformMedicalgorithmics S.A.20240—
+4K223013AccurECG Analysis SystemAccurkardia, Inc.20231—
+4K210822DeepRhythmAIMedicalgorithmics S.A.20226—
+4K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+4K200884B-Secur HeartKey Software LibraryB-Secur, Ltd.20200—
+4K201985KardiaAIAliveCor, Inc.20200—
+4K201040Bioflux Software IIBiotricity20200—
+4K193415physIQ Heart Rhythm and Respiration ModulePhysiq, Inc.20200—
+4K183319Triangle SystemAliveCor, Inc.20193—
+4K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc.201530—
+5K254255S-Patch CardioAIWellysis Corp.20260—
+5K261580ZBPro Diagnostic (Version 2.0)Zbeats, Inc.20260—
+5K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.20250—
+5K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+5K250932DeepRhythmAIMedicalgorithmics S.A.20251—
+5K242129VitalRhythmVitalconnect, Inc.20250—
+5K232670HiCardi+ H100MEZOO Co., Ltd.20240—
+5K240901StethophoneSparrow Acoustics, Inc.20241—
+5K233755HeartKey® RhythmB-Secur Limited20240—
+5K223049CardioSTAT® ECG Test SolutionIcentia, Inc.20230—
+5K203638AT-Patch ECG Analysis SystemAtsens Co., Ltd.20221—
+5K210179QOCA Portable ECG Monitoring DeviceQuanta Computer, Inc.20220—
+5K210753KardiaMobile 6LAliveCor, Inc.20212—
+5K202456M5 RecorderGlobal Instrumentation, LLC20200—
+5K173461ECG recorder and Arrhythmia DetectorSmart Solutions Technologies SL20181—
+5K171936Peerbridge Cor (TM) SystemPeerbridge Health, Inc.20171—
+5K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.2017181
+5K162503Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView SoftwareCardiac Insight, Inc.20170—
+6K253529Peerbridge COR MDx (Cor MDx)Peerbridge Health, Inc.20260—
+6K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+6K253141DeepRhythmAIMedicalgorithmics S.A.20250—
+6K252595Stethophone ProSparrow Acoustics, Inc.20250—
+6K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.20250—
+6K231424HeartBeam AIMIGo (TM) SystemHeartbeam, Inc.20240—
+6K240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.20241—
+6K233584RhythmStar SystemRhythMedix, LLC20241—
+6K231620Nuubo SmartSmart Solutions Technologies SL20230—
+6K220350KardiaMobile 6LAliveCor, Inc.20220—
+6K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc.201812—
+7K250793RhythmStar System (SL)RhythMedix, LLC20260—
+7K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.20240—
+7K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.20194—
+8K202527Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc.20213—
+9K222389ZEUS SystemiRhythm Technologies, Inc.20231—
+9K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—
+10K252859ZEUS Platform (FG0501US)iRhythm Technologies, Inc.20260—