510(k) Report

Devices descending from K930806

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K980186Zymed Telemetry SystemAgilent Technologies19983—
+1K955015Zymed Holter Scanner Model 2010Zymed Medical Instrumentation1996108—
+2K013615Micro-Induction 1000 SystemHarbinger Medical, Inc.20021—
+2K004017H-ScribeMortara Instrument, Inc.200142
+2K990093Zymed Telemetry System: Model EasiviewAgilent Technologies19990—
+2K990170Holter 2000Zymed Medical Instrumentation199989—
+2K983102Cardiac Diagnostic System Model CH 2000Cambridge Heart, Inc.19999—
+2K984089Zymed Telemetry System, Model Easi ViewZymed Medical Instrumentation19991—
+2K982090Paceart Home Trak Plus Easi Event Recorder SystemPaceart, Inc.19996—
+3K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.20250—
+3K090249Modification to: Micro-Induction 1000 SystemHarbinger Medical, Inc.20090—
+3K042002Synescope, Easyscope, Synecom, HolterreaderEla Medical, Inc.20043—
+3K020213Netlink/NetscanRozinn Electronics, Inc.20024—
+3K012206Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave Alternans…Cambridge Heart, Inc.20016—
+3K0109492010 Plus Holter for WindowsAgilent Technologies200185—
+3K0039402010 Plus Holter for WindowsAgilent Technologies20011—
+3K0037632010 Plus Holter for WindowsAgilent Technologies20010—
+3K992197Modification to Zymed Holter 2000Zymed Medical Instrumentation19990—
+4K241890Philips Holter Analysis SystemPhilips Medizin Systeme Böblingen GmbH20250—
+4K193177CER-SCardiocalm20202—
+4K142349TM eCloud ECG Analysis SystemTelemed Solutions, Inc.20150—
+4K070260Star ST and Arrhythmia Software, Release H.0Philips Medical Systems20077—
+4K051026Mars Holter Analysis WorkstationGe Medical Systems Information Technologies20058—
+4K042108Vista PlusNovacor200546—
+4K031517Zargis Acoustic CardioscanZargis Medical Corp.200419—
+4K013565Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc.20013—
+4K013564Modification to Heartwave Alternans Processing System, Model ApsCambridge Heart, Inc.20011—
+5K213861CER-SCardiocalm Srl20221—
+5K143432Cardio-TriTestCardio-Phoenix, Inc.20151—
+5K140847Cardiospy Ecg Holter SystemsLabtech Kft.20141—
+5K102111Medical Magnetic Tape RecorderWpr Medical AS20100—
+5K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+5K093141Mars Holter Analysis WorkstationGe Medical Systems Information Technologies20097—
+5K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp.200914—
+5K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086—
+5K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc.200730—
+5K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc.200740—
+5K060197Zargis Acoustic Cardioscan (Zac), Model Zac 6.28Zargis Medical Corp.200615—
+5K052283Heart STG System and SoftwareStethographics, Inc.200511—
+5K022152Heartwave Alternans Processing System, Model ApsCambridge Heart, Inc.20020—
+5K022149Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc.20022—
+6K243312CER-SCardiocalm Srl20250—
+6K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library…Medtronic, Inc.202093
+6K182790Cardio-TriTest v6.5Cardio-Phoenix, Inc.20180—
+6K182030Faros MobileBittium Biosignals, Ltd.20180—
+6K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+6K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+6K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+6K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+6K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+6K143503BioMonitorBiotronik, Inc.20159—
+6K132960BiomonitorBiotronik, Inc.201410—
+6K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc.2014231
+6K132437Mars Holter Analysis WorkstationGe Medical Systems Information Technologies, Inc.20136—
+6K122161SJM ConfirmSt Jude Medical20124—
+6K121617SensicardiacDiacoustic Medical (Pty)201210—
+6K110704SENSIDiacoustic Medical Devices (Pty), Ltd.201113—
+6K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…Medtronic, Inc.201126—
+6K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc.200828—
+6K050225Heartwave II Cardiac Diagnostic SystemCambridge Heart, Inc.20051—
+7K221962LINQ II Insertable Cardiac MonitorMedtronic, Inc.202241
+7K210484LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc.20211—
+7K211304LINQ II Insertable Cardiac MonitorMedtronic, Inc.202111
+7K193473LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic…Boston Scientific Corporation20203—
+7K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.201724
+7K162023CardioDay V2.5Getemed Medizin- Und Informationstechnik AG20171—
+7K152995BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20168—
+7K151787Holter SystemEdan Instruments, Inc.20162—
+7K150614Reveal LINQMedtronic, Inc.201515—
+7K150117Medtronic Patient AsistantMedtronic, Inc.20151—
+7K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc.20143—
+7K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd.20139—
+7K131287CardiosleeveRijuven Corp20131—
+7K100362Cambridge Heart OemCambridge Heart, Inc.20100—
+8K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd.20260—
+8K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+8K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.20250—
+8K233320LINQ II™ Insertable Cardiac Monitor (LNQ22)Medtronic, Inc.202331
+8K231328LUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp202316
+8K230553LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM ApplicationMedtronic, Inc.202301
+8K223630Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm…Medtronic, Inc.20230—
+8K210608LUX-Dx Insertable Cardiac MonitorBoston Scientific Corporation20210—
+8K201299HD StethHd Medical, Inc.20200—
+8K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+8K190574Patient Assistant Model PA97000Medtronic, Inc.20190—
+8K190548BIOMONITOR III, Remote Assistant IIIBiotronik, Inc.20195—
+8K181988eMurmur IDCsd Labs GmbH20197—
+8K182981Confirm Rx Insertable Cardiac MonitorAbbott20190—
+8K173232myMerlin (TM) Mobile Application Model APP1001St Jude Medical20170—
+8K171514BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, SetBiotronik, Inc.20170—
+8K170628BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20170—
+8K160809Reveal LINQMedtronic, Inc.201612—
+8K160689Reveal LINQMedtronic, Inc.20161—
+9K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific Corporation20250—
+9K240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.20241—
+9K233562LINQ II Insertable Cardiac MonitorMedtronic, Inc.202301
+9K230823AusculThing ACCAusculthing OY20230—
+9K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+9K220766eMurmur Heart AICsd Labs GmbH20221—
+9K200444Biomonitor III, Biomonitor IIImBiotronik, Inc.20204—