510(k) Report

Devices descending from K052303

38 later devices reach Readmyheart, Model RMH2.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112622Handheld Ecg MonitorBeijing Choice Electronic Technololgy Co., Ltd.20121—
+1K111159Heartcheck Pen Handheld Ecg with Gems HomeCardiocomm Solutions, Inc.20112—
+1K111438REKA E100Reka Pte, Ltd.201132—
+2K181310HeartCheck Cardi Beat ECG Monitor with GEMS MobileCardiocomm Solutions, Inc.20190—
+2K152863Portable ECG MonitorContec Medical Systems Co.,Ltd20160—
+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—
+3K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc.201530—
+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—
+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—