510(k) Report

Devices descending from K955015

108 later devices reach Zymed Holter Scanner Model 2010 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013615Micro-Induction 1000 SystemHarbinger Medical, Inc.20021—
+1K004017H-ScribeMortara Instrument, Inc.200142
+1K990170Holter 2000Zymed Medical Instrumentation199989—
+1K983102Cardiac Diagnostic System Model CH 2000Cambridge Heart, Inc.19999—
+1K982090Paceart Home Trak Plus Easi Event Recorder SystemPaceart, Inc.19996—
+2K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.20250—
+2K090249Modification to: Micro-Induction 1000 SystemHarbinger Medical, Inc.20090—
+2K042002Synescope, Easyscope, Synecom, HolterreaderEla Medical, Inc.20043—
+2K020213Netlink/NetscanRozinn Electronics, Inc.20024—
+2K012206Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave Alternans…Cambridge Heart, Inc.20016—
+2K0109492010 Plus Holter for WindowsAgilent Technologies200185—
+2K0039402010 Plus Holter for WindowsAgilent Technologies20011—
+2K0037632010 Plus Holter for WindowsAgilent Technologies20010—
+2K992197Modification to Zymed Holter 2000Zymed Medical Instrumentation19990—
+3K241890Philips Holter Analysis SystemPhilips Medizin Systeme Böblingen GmbH20250—
+3K193177CER-SCardiocalm20202—
+3K142349TM eCloud ECG Analysis SystemTelemed Solutions, Inc.20150—
+3K070260Star ST and Arrhythmia Software, Release H.0Philips Medical Systems20077—
+3K051026Mars Holter Analysis WorkstationGe Medical Systems Information Technologies20058—
+3K042108Vista PlusNovacor200546—
+3K031517Zargis Acoustic CardioscanZargis Medical Corp.200419—
+3K013565Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc.20013—
+3K013564Modification to Heartwave Alternans Processing System, Model ApsCambridge Heart, Inc.20011—
+4K213861CER-SCardiocalm Srl20221—
+4K143432Cardio-TriTestCardio-Phoenix, Inc.20151—
+4K140847Cardiospy Ecg Holter SystemsLabtech Kft.20141—
+4K102111Medical Magnetic Tape RecorderWpr Medical AS20100—
+4K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+4K093141Mars Holter Analysis WorkstationGe Medical Systems Information Technologies20097—
+4K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp.200914—
+4K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086—
+4K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc.200730—
+4K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc.200740—
+4K060197Zargis Acoustic Cardioscan (Zac), Model Zac 6.28Zargis Medical Corp.200615—
+4K052283Heart STG System and SoftwareStethographics, Inc.200511—
+4K022152Heartwave Alternans Processing System, Model ApsCambridge Heart, Inc.20020—
+4K022149Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc.20022—
+5K243312CER-SCardiocalm Srl20250—
+5K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library…Medtronic, Inc.202093
+5K182790Cardio-TriTest v6.5Cardio-Phoenix, Inc.20180—
+5K182030Faros MobileBittium Biosignals, Ltd.20180—
+5K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+5K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+5K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+5K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+5K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+5K143503BioMonitorBiotronik, Inc.20159—
+5K132960BiomonitorBiotronik, Inc.201410—
+5K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc.2014231
+5K132437Mars Holter Analysis WorkstationGe Medical Systems Information Technologies, Inc.20136—
+5K122161SJM ConfirmSt Jude Medical20124—
+5K121617SensicardiacDiacoustic Medical (Pty)201210—
+5K110704SENSIDiacoustic Medical Devices (Pty), Ltd.201113—
+5K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…Medtronic, Inc.201126—
+5K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc.200828—
+5K050225Heartwave II Cardiac Diagnostic SystemCambridge Heart, Inc.20051—
+6K221962LINQ II Insertable Cardiac MonitorMedtronic, Inc.202241
+6K210484LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc.20211—
+6K211304LINQ II Insertable Cardiac MonitorMedtronic, Inc.202111
+6K193473LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic…Boston Scientific Corporation20203—
+6K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.201724
+6K162023CardioDay V2.5Getemed Medizin- Und Informationstechnik AG20171—
+6K152995BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20168—
+6K151787Holter SystemEdan Instruments, Inc.20162—
+6K150614Reveal LINQMedtronic, Inc.201515—
+6K150117Medtronic Patient AsistantMedtronic, Inc.20151—
+6K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc.20143—
+6K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd.20139—
+6K131287CardiosleeveRijuven Corp20131—
+6K100362Cambridge Heart OemCambridge Heart, Inc.20100—
+7K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd.20260—
+7K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+7K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.20250—
+7K233320LINQ II™ Insertable Cardiac Monitor (LNQ22)Medtronic, Inc.202331
+7K231328LUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp202316
+7K230553LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM ApplicationMedtronic, Inc.202301
+7K223630Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm…Medtronic, Inc.20230—
+7K210608LUX-Dx Insertable Cardiac MonitorBoston Scientific Corporation20210—
+7K201299HD StethHd Medical, Inc.20200—
+7K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+7K190574Patient Assistant Model PA97000Medtronic, Inc.20190—
+7K190548BIOMONITOR III, Remote Assistant IIIBiotronik, Inc.20195—
+7K181988eMurmur IDCsd Labs GmbH20197—
+7K182981Confirm Rx Insertable Cardiac MonitorAbbott20190—
+7K173232myMerlin (TM) Mobile Application Model APP1001St Jude Medical20170—
+7K171514BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, SetBiotronik, Inc.20170—
+7K170628BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20170—
+7K160809Reveal LINQMedtronic, Inc.201612—
+7K160689Reveal LINQMedtronic, Inc.20161—
+8K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific Corporation20250—
+8K240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.20241—
+8K233562LINQ II Insertable Cardiac MonitorMedtronic, Inc.202301
+8K230823AusculThing ACCAusculthing OY20230—
+8K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+8K220766eMurmur Heart AICsd Labs GmbH20221—
+8K200444Biomonitor III, Biomonitor IIImBiotronik, Inc.20204—
+8K162855Reveal LINQMedtronic, Inc.2017111
+8K163460Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20170—
+9K262735LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)Medtronic, Inc.20260—
+9K252284eMurmur Heart AICsd Labs20250—