510(k) Report

Devices descending from K002544

148 later devices reach Medilog Excel 2 - Holter Management System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053369Medilog Darwin Holter AnalysisHuntleigh Healthcare200513—
+1K042799QRS-Card Cardiology SuitePulse Biomedical, Inc.20041—
+1K042463Holter PlusRozinn Electronics, Inc.200435—
+1K021176Compumedics Somte SystemCompumedics Limited200395—
+2K142352CardiacLinxRoss Medical Technology, Inc.20150—
+2K091075Zeus (Zio Ecg Utilization Service) SystemiRhythm Technologies, Inc.200932—
+2K083820Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-CVasomedical, Inc.200912—
+2K073682Embletta GoldEmbla Systems, Inc.2008411
+2K072201Compumedics Somte PSG Recording SystemCompumedics Limited200848—
+2K062068Intelwave Heart Rate Variability System, Version 1.0Intelwave, LLC20061—
+2K052573Stardust IIRespironics, Inc.200502
+2K040194Compumedics Summit IPCompumedics USA, Ltd.200413—
+3K192469Nox Sleep SystemNox Medical20194—
+3K142551QANS (Quantitative Autonomic Nervous System) Monitoring SystemHhssystems, LLC20150—
+3K142681ZEUS (ZIO ECG Utilization Service) SystemiRhythm Technologies, Inc.201431—
+3K122516Embletta MPREmbla Systems2013271
+3K111194Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc.201140—
+3K111180Vasomedical-Biox 12- Channel Ambulatory Ecg Holter Recorder Model 1304, Vasomedical-Biox…Vasomedical, Inc.20110—
+3K101022Pulmotrack 5050 Wholter, Model 5050Karmelsonix20106—
+3K092785Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software…Vasomedical, Inc.20103—
+3K093223Compumedics Grael System, Models: Grael, Grael EcgCompumedics Limited20101—
+3K092003CPC Sleep Data Recorder, Model M1, and Application SoftwareMyCardio, LLC20094—
+3K090273Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Kai Sensors, Inc.20097—
+3K043132Universal XacttraceMedcare Flaga200410—
+4K252330DeepRESPNox Medical Ehf20250—
+4K241960DeepRESPNox Medical Ehf20251—
+4K231104ABPMproSomnomedics GmbH20230—
+4K223539Dreem 3SBeacon Biosignals, Inc.20231—
+4K230073OktiCompumedics Limited20230—
+4K210593Onera Sleep Test System (Onera STS)Onera B.V.20223—
+4K203343Wesper LabWesper, Inc.20211—
+4K173793XactTrace Single Use Respiratory Effort Belt SystemEmbla Systems20191—
+4K163696SleepImage SystemMycardio, LLC Dba Sleepimage.20173—
+4K160499Apnea Risk Evaluation System (ARES), Model 620Watermark Medical20170—
+4K161579Watch-PAT200UItamar Medical, Ltd.201720—
+4K151940Thora-3Di, Model T-01Pneumacare Limited20163—
+4K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc.201530—
+4K112514Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc.201238—
+4K110525Vitalograph Model 7100 - VitalojakVitalograph (Ireland), Ltd.20115—
+4K103631Sleepminder Breathing Frequency IndicatorBiancamed Limited20111—
+4K111096Vasomedical-Biox Combined 12 Channel Ambulatory Ecg and Blood Pressure Recorder Model…Vasomedical, Inc.20111—
+4K100773Kai Spot Model KMS 200Kai Medical, Inc.20100—
+5K260050WRAP SystemHuneo, LLC20260—
+5K253293VitaloJAK Clinic (Model 7100)Vitalograph, Ltd.20250—
+5K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.20252—
+5K242424Bluebird Single-Use Respiratory Effort BeltCadwell Industries, Inc.20240—
+5K242094Dreem 3SBeacon Biosignals, Inc.20240—
+5K232670HiCardi+ H100MEZOO Co., Ltd.20240—
+5K230184Holter ECG and ABP SystemEdan Instruments, Inc.20230—
+5K223573Onera Sleep Test System (Onera STS)Onera B.V.20231—
+5K223049CardioSTAT® ECG Test SolutionIcentia, Inc.20230—
+5K221816Wesper LabWesper, Inc.20230—
+5K203638AT-Patch ECG Analysis SystemAtsens Co., Ltd.20221—
+5K210179QOCA Portable ECG Monitoring DeviceQuanta Computer, Inc.20220—
+5K203839WatchPAT200U (WP200U)Itamar Medical, Ltd.20224—
+5K202456M5 RecorderGlobal Instrumentation, LLC20200—
+5K201077Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs20203—
+5K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.20200—
+5K191031NightOwlEctosense NV20205—
+5K182618SleepImage SystemMycardio, LLC Dba Sleepimage.20192—
+5K180775Watch-PAT300Itamar Medical, Ltd.201812—
+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—
+5K140190Night ShiftAdvanced Brain Monitoring, Inc.20141—
+5K130007Sleep ProfilerAdvanced Brain Monitoring, Inc.201314—
+5K130013X4 SystemAdvanced Brain Monitoring, Inc.201317—
+5K120450Sleep ProfilerAdvanced Brain Monitoring, Inc.201216—
+5K120447X4Advanced Brain Monitoring, Inc.201218—
+6K253529Peerbridge COR MDx (Cor MDx)Peerbridge Health, Inc.20260—
+6K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+6K252628CassieWesper, Inc.20260—
+6K243220Onera STS 2 (ONERA STS 2)Onera B.V.20250—
+6K242224Happy Health Home Sleep TestHappy Health, Inc.20250—
+6K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.20250—
+6K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.20251—
+6K240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.20241—
+6K233584RhythmStar SystemRhythMedix, LLC20241—
+6K231355AuroraEnsodata20240—
+6K231546SomfitCompumedics Limited20231—
+6K231620Nuubo SmartSmart Solutions Technologies SL20230—
+6K222331WatchPAT300 (WP300)Itamar Medical, Ltd.20223—
+6K220893Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs, Inc.20222—
+6K213463NightOwlEctosense NV20213—
+6K183559WatchPAT ONEItamar Medical, Ltd.20195—
+6K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc.201812—
+6K180608Lunoa SystemNightbalance BV20180—
+6K153412Sleep ProfilerAdvanced Brain Monitoring, Inc.201613—
+6K152040X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System -…Advanced Brain Monitoring, Inc.20151—
+6K142825ZmachineConsolidated Research of Richmond, Inc.20150—
+6K131383X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic SoftwareAdvanced Brain Monitoring, Inc.201314—
+7K253650Anura Mobile Core SDK (M1)Nuralogix Corporation20260—
+7K250793RhythmStar System (SL)RhythMedix, LLC20260—
+7K252383Somfit DCompumedics Limited20250—
+7K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.20240—
+7K233403Flexset SystemZeto, Inc.20241—
+7K233438SleepStageMLBeacon Biosignals, Inc.20240—
+7K223382AeviceMDAevice Health Pte., Ltd.20231—
+7K223675WatchPAT ONE (WP1)Itamar Medical, Ltd.20232—