510(k) Report

Devices descending from K943862

85 later devices reach Sonicaid Model MR-63 Ambulatory Ecg Recorder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K970902Medilog FD4Oxford Instruments Medical Systems199784—
+2K070818MEDILOGAR4, MEDILOGAR12Tom Medical Entwicklungs GmbH200714—
+2K990727Syneflash & SyneviewEla Medical, Inc.199968—
+3K253562medilogFDSchiller AG20260—
+3K083820Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-CVasomedical, Inc.200912—
+3K042002Synescope, Easyscope, Synecom, HolterreaderEla Medical, Inc.20043—
+3K032466SpiderviewEla Medical, Inc.200356—
+3K031466Iqmark Digital HolterBrentwood Medical Technology Corp.20036—
+4K193177CER-SCardiocalm20202—
+4K142693ZywieAI Software LibraryZywie, Inc.20150—
+4K140847Cardiospy Ecg Holter SystemsLabtech Kft.20141—
+4K111180Vasomedical-Biox 12- Channel Ambulatory Ecg Holter Recorder Model 1304, Vasomedical-Biox…Vasomedical, Inc.20110—
+4K102723Model 950-12L Holter Recorder Without AnalysisMemtec Corp.20103—
+4K101022Pulmotrack 5050 Wholter, Model 5050Karmelsonix20106—
+4K092785Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software…Vasomedical, Inc.20103—
+4K063035Sleuth Implantable Ecg Monitoring SystemTransnoma Medical, Inc.20073—
+4K062088Premier 11 HolterDiagnostic Monitoring Software20060—
+4K043010Holter Recorder H3+Mortara Instrument, Inc.20054—
+4K042108Vista PlusNovacor200546—
+5K231104ABPMproSomnomedics GmbH20230—
+5K213861CER-SCardiocalm Srl20221—
+5K181658MobileECG 2 BTMemtec Corporation20190—
+5K182030Faros MobileBittium Biosignals, Ltd.20180—
+5K152626H3+ Holter RecorderMortara Instrument, Inc.20160—
+5K151787Holter SystemEdan Instruments, Inc.20162—
+5K110525Vitalograph Model 7100 - VitalojakVitalograph (Ireland), Ltd.20115—
+5K103706The Core (Cardiac Outpatient Realtime Ecg) MonitorApplied Cardiac Systems, Inc.20111—
+5K111096Vasomedical-Biox Combined 12 Channel Ambulatory Ecg and Blood Pressure Recorder Model…Vasomedical, Inc.20111—
+5K102111Medical Magnetic Tape RecorderWpr Medical AS20100—
+5K083828Sleuth at Implantable Cardiac Monitoring System -6 CM and 8CM Antenna, Personal…Transoma20091—
+5K073147Sleuth Implantable Ecg System-8 CM Accessory Kit, Model 3000-08Transoma Medical20072—
+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—
+6K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd.20260—
+6K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+6K253293VitaloJAK Clinic (Model 7100)Vitalograph, Ltd.20250—
+6K243312CER-SCardiocalm Srl20250—
+6K230184Holter ECG and ABP SystemEdan Instruments, Inc.20230—
+6K201077Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs20203—
+6K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library…Medtronic, Inc.202093
+6K143503BioMonitorBiotronik, Inc.20159—
+6K142352CardiacLinxRoss Medical Technology, Inc.20150—
+6K132960BiomonitorBiotronik, Inc.201410—
+6K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc.2014231
+6K122161SJM ConfirmSt Jude Medical20124—
+6K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…Medtronic, Inc.201126—
+6K091206Sleuth at Implantable Cardiac Monitoring System-6 and 8CM Antenna, Personal Diagnostic…Transoma Medical20090—
+6K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc.200828—
+7K221962LINQ II Insertable Cardiac MonitorMedtronic, Inc.202241
+7K220893Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs, Inc.20222—
+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
+7K152995BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20168—
+7K150614Reveal LINQMedtronic, Inc.201515—
+7K150117Medtronic Patient AsistantMedtronic, Inc.20151—
+7K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc.20143—
+8K233320LINQ II™ Insertable Cardiac Monitor (LNQ22)Medtronic, Inc.202331
+8K231328LUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp202316
+8K223382AeviceMDAevice Health Pte., Ltd.20231—
+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—
+8K190574Patient Assistant Model PA97000Medtronic, Inc.20190—
+8K190548BIOMONITOR III, Remote Assistant IIIBiotronik, Inc.20195—
+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—
+9K243603AeviceMDAevice Health Pte., Ltd.20250—
+9K240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.20241—
+9K233562LINQ II Insertable Cardiac MonitorMedtronic, Inc.202301
+9K200444Biomonitor III, Biomonitor IIImBiotronik, Inc.20204—
+9K162855Reveal LINQMedtronic, Inc.2017111
+9K163460Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20170—
+10K262735LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)Medtronic, Inc.20260—
+10K212008Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20210—
+10K201865Biomonitor III, Biomonitor IIImBiotronik, Inc.20203—
+11K221856BIOMONITOR IIIm, BIOMONITOR IIIBiotronik, Inc.20222—
+12K230375Biomonitor IVBiotronik, Inc.20231—
+13K261074Biomonitor IV (471155)Biotronik, Inc.20260—