510(k) Report

Devices descending from K991735

81 later devices reach Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc.20170—
+1K071168The Portable AnsiscopeDyansys, Inc.20077—
+1K014108Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn200271—
+2K241217CloudHRV™ System (100-01-001)Inmedix, Inc.20250—
+2K142969ANI MonitorMdoloris Medical Systems Sas20160—
+2K123130Answatch Wrist Monitor Model TS-0411Taiwan Scientific Corporation20132—
+2K120188ElectrocardiographEdan Instruments, Inc.20120—
+2K111805Ecg Series ElectrocardiographAdvanced Instrumentations, Inc.20110—
+2K102830ElectrocardiographEdan Instruments, Inc.20109—
+2K091513Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12…Edan Instruments, Inc.2009321
+2K082709Vicor PD2I Analyzer, Version 2.1Vicor Technologies, Inc.20081—
+2K033492Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies200331—
+2K024283Cardiodirect, Models 12M, 12I, 12SReynolds Medical, Ltd.20034—
+3K213699CareTaker Monitor AppCaretaker Medical, LLC20220—
+3K201914HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation20210—
+3K171943ElectrocardiographEdan Instruments, Inc.20171—
+3K160876PC ECGEdan Instruments, Inc.20178—
+3K141946Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20153—
+3K123148Parace MD Ekoscope IS100Parace, LLC20130—
+3K130207Spacelabs Healthcare CardioexpressSpacelabs Healthcare, Ltd.20130—
+3K101867Vicor PD2I AnalyzerVicor Technologies, Inc.20110—
+3K101876Digital Electrocardiograph, Models Ecg-1210, Ecg-1230, Ecg-3010, Ecg-6010Shenzhen Biocare Electronics Co., Ltd.201113—
+3K093211Carecenter MDCardiac Science Corporation20101—
+3K082380Vicardio 12BEnergy-Lab Technologies GmbH20080—
+3K062469Voyager 12Del Mar Reynolds Medical, Ltd.20060—
+3K042177Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies200430—
+4K232816Electrocardiograph, model: ECG301Shenzhen LE Medical Technology Co., Ltd.20240—
+4K171942ElectrocardiographEdan Instruments, Inc.20183—
+4K171517Digital ElectrocardiographBiocare Bio-Medical Equipment Co., Ltd.20180—
+4K170995ElectrocardiographEdan Instruments, Inc.20173—
+4K160092Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20161—
+4K131858Digital ElectrocardiographGuangdong Biolight Meditech Co., Ltd.20140—
+4K123217CardeascreenCardea Associates, Inc.20130—
+4K122712Digital ElectrocardiographShenzhen Biocare Electronics Co., Ltd.20128—
+4K113485ElectrocardiographShenzhen Carewell Electronics Co., Ltd.20123—
+4K112431Digital ElectrocardiographShenzhen Biocare Electronics Co., Ltd.20119—
+4K073625Modification to: Mac 5500 Resting Ecg Analysis SystemGe Healthcare Systems Information Technologies20087—
+4K06083312SL Ecg Analysis ProgramGe Medical Systems Information Technologies200621—
+5K233266Mediblu Ecg SystemMediblu Medical, LLC20240—
+5K212278ElectrocardiographEdan Instruments, Inc.20222—
+5K220362LE-12CHCaf Medical Solutions, Inc.20220—
+5K210140electrocardiograph: SE-1202Edan Instruments, Inc.20211—
+5K180432AI-ECG PlatformShenzhen Carewell Electronics., Ltd.20180—
+5K142288MAC 800 Resting ECG Analysis SystemGe Medical Systems China Co., Ltd.20140—
+5K131900Contec ElectrocardiographContec Medical System Co., Ltd.20141—
+5K132758Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20141—
+5K133622Mac 2000 Ecg Analysis SystemWipro GE Healthcare20141—
+5K131262Digital ElectrocardiographsSonoscape Company Limited20130—
+5K123816Digital ElectrocardiographsShenzhen Biocare Electronics Co., Ltd.20134—
+5K103765Mac 600 Resting Ecg Analysis SystemGe Medical Systems Information Technologies, Inc.20110—
+5K110266Mac 5500 HD, Mac 3500Ge Medical Systems Information Technologies, Inc.20111—
+5K09236912SL Ecg Analysis ProgramGe Medical Systems Information Technologies201019—
+5K093172Quantitative Electrocardiographic Detector (Qed 1000)Dynacardia, Inc.20100—
+5K092663Eli 350 ElectrocardiographMortara Instrument, Inc.200901
+6K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.20260—
+6K230834CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800HTrismed Co., Ltd.20230—
+6K222902Electrocardiograph: SE-1200 Pro and SE-1201 ProEdan Instruments, Inc.20231—
+6K171360CONTEC™ ElectrocardiographContec Medical Systems Co.,Ltd20180—
+6K162012CARESCAPE Central Station V2GE Healthcare201676
+6K152135Quantitative Electrocardiographic Detector (QED 2000)Acme Portable Machines, Inc.20160—
+6K14196312SL Ecg Analysis ProgramGe Medical Systems Information Technologies, Inc.20156—
+6K133985Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20151—
+6K133882Carescape Central Station (Formally Known as Cic Pro)Ge Medical Systems Information Technologies, Inc.201491
+6K103791Physioglove ES with Ecg AnalysisCommwell, Ltd.20111—
+7K231010CorvairAliveCor, Inc.20241—
+7K232210X-trodes System MX-Trodes20240—
+7K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+7K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc.20182—
+7K170155EK12 AlgorithmGe Medical Systems Information Technologies, Inc.20171—
+7K160718Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien201601
+7K152993MUSE Cardiology Information SystemGe Medical Systems Information Technologies, Inc.201611
+7K152384Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20150—
+7K133703Physioglove ET SystemCommwell R&D, Ltd.20140—
+8K252589Corvair MonzaAliveCor, Inc.20260—
+8K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+8K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+8K221904EK12 V2 AlgorithmGe Medical Systems Information Technologies, Inc.20220—
+8K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+8K201060Cordiana Dx16Cordiana Medical Informatics AG20200—
+9K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+9K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401