510(k) Report

Devices descending from K072558

67 later devices reach Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133753Mome Ecg Continuous Detection and Arrhythmia DetectorInfobionic, Inc.20141—
+1K124060Medical Gorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A.20135—
+1K112921Medicalgorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A.20127—
+1K111917Nuvant, Mobile Cardiac TelemetryCorventis, Inc.201130—
+1K102507Area-CT, TZ Medical Mcot Ecg Monitor and Arrhythmia DetectorTz Medical, Inc.20110—
+1K091971Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) SystemCorventis, Inc.200938—
+1K090037Medicalgorithmics Real-Time Ecg Monitor and Arrhythmia Detector, Model PocketecgMedicalgorithmics SP Z.O.O.20097—
+1K083287Avivo Mobile Patient Management SystemCorventis, Inc.200957—
+2K173969Medicalgorithmics Unified Cardiac Rehabilitation SystemMedicalgorithmics S.A.20180—
+2K171019ScioCardio ECG TransmitterSynergen Technology Labs, LLC20180—
+2K152491MoMe Software PlatformInfobionic, Inc.20150—
+2K152550Medicalgorithmics Unified Arrhythmia Diagnosic SystemMedicalgorithmics S.A.20153—
+2K142476Master Caution Device MCDHealthwatch, Ltd.20156—
+2K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc.20141—
+2K121197Bodyguardian System Bodyguardian Control Unit Bodyguardian ConnectPreventice, Inc.201210—
+2K113372Nuvant, Mobilc Cardiac TelemetryCorventis, Inc.201224—
+2K113187Avivo Mobile Patient ManagementCorventis, Inc.20125—
+2K100155Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp.20106—
+2K090696Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemCorventis, Inc.200940—
+3K193296eCordum Cardiac Monitor (eCordum CM)Ecordum, Inc.20203—
+3K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.20201—
+3K193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.20200—
+3K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+3K173248CardioskinBioserenity Sas20180—
+3K172510µCor Heart Failure and Arrhythmia Management SystemZoll Manufacturing Corporation20181—
+3K162956Nowcardio SystemContex International Technologies (Canada), Inc.20171—
+3K161431SimplECGNanowear, Inc.20165—
+3K153160AVIVO Mobile Patient Management (MPM) SystemMedtronic, Inc.20160—
+3K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20163—
+3K142087Cova Monitoring SystemTosense, Inc.20151—
+3K133701Nuvant MCT SystemCorventis, Inc.201423—
+3K131000V-Patch SystemIntelesens Limited20140—
+3K102111Medical Magnetic Tape RecorderWpr Medical AS20100—
+4K241179Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc.20250—
+4K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.20250—
+4K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20231—
+4K231276SmartCardia 7L PlatformSmartcardia SA20230—
+4K231620Nuubo SmartSmart Solutions Technologies SL20230—
+4K222842V-Patch Cardiac MonitorShandong Corecare Technology Limited20221—
+4K201669SimpleSENSENanowear, Inc.20203—
+4K190939ZOLL Arrhythmia Management SysyemZoll Manufacturing Corporation20190—
+4K182532Liba3 SystemNational Cardiac, Inc.20190—
+4K160899CoVa Monitoring System 2Tosense, Inc.20170—
+4K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.2017181
+5K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+5K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.20250—
+5K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.20250—
+5K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.20250—
+5K240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.20241—
+5K233584RhythmStar SystemRhythMedix, LLC20241—
+5K212160SimpleSENSE PlatformNanowear, Inc.20211—
+5K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc.201812—
+6K250793RhythmStar System (SL)RhythMedix, LLC20260—
+6K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.20240—
+6K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+6K210822DeepRhythmAIMedicalgorithmics S.A.20226—
+6K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.20194—
+7K254255S-Patch CardioAIWellysis Corp.20260—
+7K241197DeepRhythmAIMedicalgorithmics S.A.20243—
+7K233755HeartKey® RhythmB-Secur Limited20240—
+7K202527Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc.20213—
+8K250932DeepRhythmAIMedicalgorithmics S.A.20251—
+8K242129VitalRhythmVitalconnect, Inc.20250—
+8K222389ZEUS SystemiRhythm Technologies, Inc.20231—
+8K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—
+9K252859ZEUS Platform (FG0501US)iRhythm Technologies, Inc.20260—
+9K253141DeepRhythmAIMedicalgorithmics S.A.20250—