510(k) Report

Devices descending from K091971

38 later devices reach Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113187Avivo Mobile Patient ManagementCorventis, Inc.20125—
+1K111917Nuvant, Mobile Cardiac TelemetryCorventis, Inc.201130—
+1K100155Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp.20106—
+2K172510µCor Heart Failure and Arrhythmia Management SystemZoll Manufacturing Corporation20181—
+2K153160AVIVO Mobile Patient Management (MPM) SystemMedtronic, Inc.20160—
+2K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20163—
+2K142087Cova Monitoring SystemTosense, Inc.20151—
+2K131000V-Patch SystemIntelesens Limited20140—
+2K113372Nuvant, Mobilc Cardiac TelemetryCorventis, Inc.201224—
+2K102507Area-CT, TZ Medical Mcot Ecg Monitor and Arrhythmia DetectorTz Medical, Inc.20110—
+3K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20231—
+3K231276SmartCardia 7L PlatformSmartcardia SA20230—
+3K190939ZOLL Arrhythmia Management SysyemZoll Manufacturing Corporation20190—
+3K160899CoVa Monitoring System 2Tosense, Inc.20170—
+3K133701Nuvant MCT SystemCorventis, Inc.201423—
+4K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.20250—
+4K231620Nuubo SmartSmart Solutions Technologies SL20230—
+4K162956Nowcardio SystemContex International Technologies (Canada), Inc.20171—
+4K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.2017181
+5K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+5K240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.20241—
+5K233584RhythmStar SystemRhythMedix, LLC20241—
+5K182532Liba3 SystemNational Cardiac, Inc.20190—
+5K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc.201812—
+6K250793RhythmStar System (SL)RhythMedix, LLC20260—
+6K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.20240—
+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—