510(k) Report

Devices descending from K981394

51 later devices reach Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042022E-Tac EX-1000 Electrocardiographic Event RecorderDatrix, Inc. Dba of Jon Barron, Inc.200442—
+1K030856ER800 Series Ecg Event RecorderBraemar Corp.20036—
+1K992584PE 501 PC-Ecg MonitorNhe Corp.20000—
+2K111160Intricon Datrix Centauri MT Ambulatory Patient Ecg Telemetry System (Apets)Intricon Datrix Corporation20110—
+2K090696Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemCorventis, Inc.200940—
+2K061293Telaheart Digital RecorderNorth East Monitoring, Inc.20065—
+3K142424DR300 Holter MonitorNorth East Monitoring, Inc.20143—
+3K113187Avivo Mobile Patient ManagementCorventis, Inc.20125—
+3K102111Medical Magnetic Tape RecorderWpr Medical AS20100—
+3K091971Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) SystemCorventis, Inc.200938—
+3K070014Auto Detect for Telaheart DR200/E-aNorth East Monitoring, Inc.20070—
+4K172510µCor Heart Failure and Arrhythmia Management SystemZoll Manufacturing Corporation20181—
+4K153160AVIVO Mobile Patient Management (MPM) SystemMedtronic, Inc.20160—
+4K151787Holter SystemEdan Instruments, Inc.20162—
+4K142087Cova Monitoring SystemTosense, Inc.20151—
+4K111917Nuvant, Mobile Cardiac TelemetryCorventis, Inc.201130—
+4K100155Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp.20106—
+5K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd.20260—
+5K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+5K190939ZOLL Arrhythmia Management SysyemZoll Manufacturing Corporation20190—
+5K160899CoVa Monitoring System 2Tosense, Inc.20170—
+5K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20163—
+5K131000V-Patch SystemIntelesens Limited20140—
+5K113372Nuvant, Mobilc Cardiac TelemetryCorventis, Inc.201224—
+5K102507Area-CT, TZ Medical Mcot Ecg Monitor and Arrhythmia DetectorTz Medical, Inc.20110—
+6K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20231—
+6K231276SmartCardia 7L PlatformSmartcardia SA20230—
+6K133701Nuvant MCT SystemCorventis, Inc.201423—
+7K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.20250—
+7K231620Nuubo SmartSmart Solutions Technologies SL20230—
+7K162956Nowcardio SystemContex International Technologies (Canada), Inc.20171—
+7K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.2017181
+8K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+8K240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.20241—
+8K233584RhythmStar SystemRhythMedix, LLC20241—
+8K182532Liba3 SystemNational Cardiac, Inc.20190—
+8K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc.201812—
+9K250793RhythmStar System (SL)RhythMedix, LLC20260—
+9K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.20240—
+9K210822DeepRhythmAIMedicalgorithmics S.A.20226—
+9K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.20194—
+10K254255S-Patch CardioAIWellysis Corp.20260—
+10K241197DeepRhythmAIMedicalgorithmics S.A.20243—
+10K233755HeartKey® RhythmB-Secur Limited20240—
+10K202527Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc.20213—
+11K250932DeepRhythmAIMedicalgorithmics S.A.20251—
+11K242129VitalRhythmVitalconnect, Inc.20250—
+11K222389ZEUS SystemiRhythm Technologies, Inc.20231—
+11K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—
+12K252859ZEUS Platform (FG0501US)iRhythm Technologies, Inc.20260—
+12K253141DeepRhythmAIMedicalgorithmics S.A.20250—