510(k) Report

Devices descending from K930564

47 later devices reach Holter for Windows through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081861Holter LX AnalysisNorth East Monitoring, Inc.20080—
+1K051471CardiodayGetemed Medizin- Und Informationstechnik AG20054—
+1K042799QRS-Card Cardiology SuitePulse Biomedical, Inc.20041—
+1K042002Synescope, Easyscope, Synecom, HolterreaderEla Medical, Inc.20043—
+1K042463Holter PlusRozinn Electronics, Inc.200435—
+2K193177CER-SCardiocalm20202—
+2K142352CardiacLinxRoss Medical Technology, Inc.20150—
+2K091075Zeus (Zio Ecg Utilization Service) SystemiRhythm Technologies, Inc.200932—
+2K070280Cardioday, Version 2.0Getemed Medizin- Und Informationstechnik AG20073—
+2K062068Intelwave Heart Rate Variability System, Version 1.0Intelwave, LLC20061—
+3K213861CER-SCardiocalm Srl20221—
+3K142551QANS (Quantitative Autonomic Nervous System) Monitoring SystemHhssystems, LLC20150—
+3K142681ZEUS (ZIO ECG Utilization Service) SystemiRhythm Technologies, Inc.201431—
+3K130516CardiodayGetemed Medizin- Und Informationstechnik AG20132—
+4K243312CER-SCardiocalm Srl20250—
+4K162023CardioDay V2.5Getemed Medizin- Und Informationstechnik AG20171—
+4K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc.201530—
+5K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.20250—
+5K232670HiCardi+ H100MEZOO Co., Ltd.20240—
+5K223049CardioSTAT® ECG Test SolutionIcentia, Inc.20230—
+5K203638AT-Patch ECG Analysis SystemAtsens Co., Ltd.20221—
+5K210179QOCA Portable ECG Monitoring DeviceQuanta Computer, Inc.20220—
+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—
+6K240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.20241—
+6K233584RhythmStar SystemRhythMedix, LLC20241—
+6K231620Nuubo SmartSmart Solutions Technologies SL20230—
+6K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc.201812—
+7K250793RhythmStar System (SL)RhythMedix, LLC20260—
+7K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.20240—
+7K210822DeepRhythmAIMedicalgorithmics S.A.20226—
+7K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.20194—
+8K254255S-Patch CardioAIWellysis Corp.20260—
+8K241197DeepRhythmAIMedicalgorithmics S.A.20243—
+8K233755HeartKey® RhythmB-Secur Limited20240—
+8K202527Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc.20213—
+9K250932DeepRhythmAIMedicalgorithmics S.A.20251—
+9K242129VitalRhythmVitalconnect, Inc.20250—
+9K222389ZEUS SystemiRhythm Technologies, Inc.20231—
+9K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—
+10K252859ZEUS Platform (FG0501US)iRhythm Technologies, Inc.20260—
+10K253141DeepRhythmAIMedicalgorithmics S.A.20250—