510(k) Report

Devices descending from K950944

105 later devices reach Ambulatory (Holter) Recording System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030856ER800 Series Ecg Event RecorderBraemar Corp.20036—
+1K012825HearttrendsLev-El, Ltd.20020—
+1K993617Digitrakplus Holter RecorderBraemar Corp.199962—
+1K993618DXP1000 Holter RecorderBraemar Corp.199943—
+2K140847Cardiospy Ecg Holter SystemsLabtech Kft.20141—
+2K112573Ezsleep Sleep Quality RecorderPlatinum Team Co., Ltd.20120—
+2K113176Mysense HeartCardiac Science Corporation201116—
+2K102723Model 950-12L Holter Recorder Without AnalysisMemtec Corp.20103—
+2K083382Chroma, Model: RZ153CScottcare Corporation20090—
+2K071085E3-80 Portable Ecg Recorder & AnalyzerMicro-Star International Co., Ltd.20073—
+2K070818MEDILOGAR4, MEDILOGAR12Tom Medical Entwicklungs GmbH200714—
+2K061293Telaheart Digital RecorderNorth East Monitoring, Inc.20065—
+2K043010Holter Recorder H3+Mortara Instrument, Inc.20054—
+2K042108Vista PlusNovacor200546—
+2K031074Digital Ambulatory Ecg (Holter) RecorderDatrix20031—
+2K032276Click HolterRemco Italia S.P.A.20030—
+2K032466SpiderviewEla Medical, Inc.200356—
+3K253562medilogFDSchiller AG20260—
+3K181658MobileECG 2 BTMemtec Corporation20190—
+3K182030Faros MobileBittium Biosignals, Ltd.20180—
+3K152626H3+ Holter RecorderMortara Instrument, Inc.20160—
+3K151787Holter SystemEdan Instruments, Inc.20162—
+3K142424DR300 Holter MonitorNorth East Monitoring, Inc.20143—
+3K131190MypatchDms-Service, LLC201315—
+3K112601Intricon Datrix Sirona Event/ Holter RecorderIntricon Datrix Corporation20110—
+3K103706The Core (Cardiac Outpatient Realtime Ecg) MonitorApplied Cardiac Systems, Inc.20111—
+3K101569V-Trust Model TD-2202 Portable Ecg RecorderTaidoc Technology Corporation20112—
+3K102111Medical Magnetic Tape RecorderWpr Medical AS20100—
+3K083820Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-CVasomedical, Inc.200912—
+3K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc.200730—
+3K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc.200740—
+3K070014Auto Detect for Telaheart DR200/E-aNorth East Monitoring, Inc.20070—
+4K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd.20260—
+4K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+4K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library…Medtronic, Inc.202093
+4K172221VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100Taidoc Technology Corporation20180—
+4K171410ePatchBraemar Manufacturing, LLC20187—
+4K160704myPatch-sDms-Service, LLC201614—
+4K143503BioMonitorBiotronik, Inc.20159—
+4K142352CardiacLinxRoss Medical Technology, Inc.20150—
+4K132960BiomonitorBiotronik, Inc.201410—
+4K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc.2014231
+4K131572Micro Ambulatory Ecg RecorderDimetek Digital Medical Technologies, Ltd.20130—
+4K122161SJM ConfirmSt Jude Medical20124—
+4K111180Vasomedical-Biox 12- Channel Ambulatory Ecg Holter Recorder Model 1304, Vasomedical-Biox…Vasomedical, Inc.20110—
+4K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…Medtronic, Inc.201126—
+4K101022Pulmotrack 5050 Wholter, Model 5050Karmelsonix20106—
+4K092785Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software…Vasomedical, Inc.20103—
+4K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc.200828—
+5K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.20260—
+5K231104ABPMproSomnomedics GmbH20230—
+5K231289S-Patch Ex Wearable ECG PatchWellysis Corp.20233—
+5K221962LINQ II Insertable Cardiac MonitorMedtronic, Inc.202241
+5K211709BiotresBiotricity20222—
+5K210484LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc.20211—
+5K211304LINQ II Insertable Cardiac MonitorMedtronic, Inc.202111
+5K193473LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic…Boston Scientific Corporation20203—
+5K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.201724
+5K163535my Patch slDms-Service, LLC20175—
+5K152995BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20168—
+5K150614Reveal LINQMedtronic, Inc.201515—
+5K150117Medtronic Patient AsistantMedtronic, Inc.20151—
+5K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc.20143—
+5K110525Vitalograph Model 7100 - VitalojakVitalograph (Ireland), Ltd.20115—
+5K111096Vasomedical-Biox Combined 12 Channel Ambulatory Ecg and Blood Pressure Recorder Model…Vasomedical, Inc.20111—
+6K253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7…Seers Technology Co., Ltd.20260—
+6K253293VitaloJAK Clinic (Model 7100)Vitalograph, Ltd.20250—
+6K233864ASSURE Wearable ECGKestra Medical Technologies, Inc.20240—
+6K233906S-Patch (S-Patch ExL)Wellysis Corp.20240—
+6K233320LINQ II™ Insertable Cardiac Monitor (LNQ22)Medtronic, Inc.202331
+6K230184Holter ECG and ABP SystemEdan Instruments, Inc.20230—
+6K231328LUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp202316
+6K230553LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM ApplicationMedtronic, Inc.202301
+6K223630Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm…Medtronic, Inc.20230—
+6K222017BiotresBiotricity20220—
+6K210758Q PatchMedicalgorithmics S.A.20221—
+6K203168LifeLens Wireless ECG MonitorLifeLens Technologies, Inc.20211—
+6K210608LUX-Dx Insertable Cardiac MonitorBoston Scientific Corporation20210—
+6K202456M5 RecorderGlobal Instrumentation, LLC20200—
+6K201077Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs20203—
+6K190574Patient Assistant Model PA97000Medtronic, Inc.20190—
+6K190548BIOMONITOR III, Remote Assistant IIIBiotronik, Inc.20195—
+6K182981Confirm Rx Insertable Cardiac MonitorAbbott20190—
+6K173232myMerlin (TM) Mobile Application Model APP1001St Jude Medical20170—
+6K171514BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, SetBiotronik, Inc.20170—
+6K170628BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20170—
+6K160809Reveal LINQMedtronic, Inc.201612—
+6K160689Reveal LINQMedtronic, Inc.20161—
+7K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+7K252839ZywieZ3 Sensor & AdhesiveZywie, Inc.20260—
+7K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific Corporation20250—
+7K240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.20241—
+7K233562LINQ II Insertable Cardiac MonitorMedtronic, Inc.202301
+7K220893Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs, Inc.20222—
+7K200444Biomonitor III, Biomonitor IIImBiotronik, Inc.20204—
+7K162855Reveal LINQMedtronic, Inc.2017111
+7K163460Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20170—
+8K262735LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)Medtronic, Inc.20260—
+8K223382AeviceMDAevice Health Pte., Ltd.20231—
+8K212008Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20210—