510(k) Report

Devices descending from K060766

55 later devices reach Portable, Electrocardiograph (Ecg) Monitor, Model HCG-801 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131572Micro Ambulatory Ecg RecorderDimetek Digital Medical Technologies, Ltd.20130—
+1K111438REKA E100Reka Pte, Ltd.201132—
+1K110328Acg-8511 Portable Ecg MonitorAndon Health Co, Ltd.20110—
+1K103077Ecg PenMeridian Dynamics Biomedical, Inc.20110—
+1K101569V-Trust Model TD-2202 Portable Ecg RecorderTaidoc Technology Corporation20112—
+1K093872Handheld Ecg Monitor, Model MD100Beijing Choice Electronic Technololgy Co., Ltd.201037—
+1K082013Clue Medical and Clue Medical BasicTelovital GmbH Telemedizin20081—
+1K080933Handheld Ecg Monitor, Model MD100Beijing Choice Electronic Technololgy Co., Ltd.20081—
+1K073152PC-180 / Prince 180 Easy Ecg MonitorShenzhen Creative Industry Co., Ltd.20080—
+1K061123Palm Ecg Recorder, Model EP-201/202Parama-Tech Company., Ltd.20070—
+1K062894Instantcheck RTD-Ecg Monitor, Model RMH4.0Dailycare Biomedical, Inc.20076—
+2K172221VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100Taidoc Technology Corporation20180—
+2K170954Portable ECG MonitorContec Medical Systems Co.,Ltd20170—
+2K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+2K121628Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd.201331—
+2K121009Heartcheck Ecg Pen with Gems HomeCardiocomm Solutions, Inc.20120—
+2K111159Heartcheck Pen Handheld Ecg with Gems HomeCardiocomm Solutions, Inc.20112—
+2K083630Clue Medical and Clue Medical BasicTelovital GmbH Telemedizin20090—
+3K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+3K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+3K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+3K181310HeartCheck Cardi Beat ECG Monitor with GEMS MobileCardiocomm Solutions, Inc.20190—
+3K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc.201530—
+4K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+4K232670HiCardi+ H100MEZOO Co., Ltd.20240—
+4K223049CardioSTAT® ECG Test SolutionIcentia, Inc.20230—
+4K203638AT-Patch ECG Analysis SystemAtsens Co., Ltd.20221—
+4K210179QOCA Portable ECG Monitoring DeviceQuanta Computer, Inc.20220—
+4K213515WesperO2Wesper, Inc.20220—
+4K202456M5 RecorderGlobal Instrumentation, LLC20200—
+4K173461ECG recorder and Arrhythmia DetectorSmart Solutions Technologies SL20181—
+4K171936Peerbridge Cor (TM) SystemPeerbridge Health, Inc.20171—
+4K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.2017181
+4K162503Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView SoftwareCardiac Insight, Inc.20170—
+5K253529Peerbridge COR MDx (Cor MDx)Peerbridge Health, Inc.20260—
+5K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+5K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.20250—
+5K240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.20241—
+5K233584RhythmStar SystemRhythMedix, LLC20241—
+5K231620Nuubo SmartSmart Solutions Technologies SL20230—
+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—