510(k) Report

Devices descending from K964750

115 later devices reach Eagle 4000 Patient Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc.20170—
+1K070232Ecg Cables, Trunk and Patient Lead WiresAmerican I.V. Products, Inc.20070—
+1K06030712 RL AlgorithmGe Medical Systems Information Technologies20065—
+1K991735Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac 8…General Electric Medical Systems Information Techn199981—
+1K973486Life Pak 12Physio-Control Corp.1998243
+1K971683Wireless Lan (Local Area Network) - Wireless EthernetMarquette Electronics, Inc.19970—
+2K102972Lifepak 12Physio-Control, Inc.201001
+2K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+2K082937Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc.200953
+2K071168The Portable AnsiscopeDyansys, Inc.20077—
+2K063510Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc.200772
+2K041459Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc.20049—
+2K040775Lifepak 12Medtronic Physio-Control Corp.2004101
+2K030898Mobile Battery Service Station (MBSS)Ad Elektronik GmbH20030—
+2K012274Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp.20022117
+2K014108Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn200271—
+2K991910Lifepak 12 BiphasicPhysio-Control Corp.1999223
+3K241217CloudHRV™ System (100-01-001)Inmedix, Inc.20250—
+3K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+3K142969ANI MonitorMdoloris Medical Systems Sas20160—
+3K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+3K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+3K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+3K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc.20142Class I
+3K123130Answatch Wrist Monitor Model TS-0411Taiwan Scientific Corporation20132—
+3K130454Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorPhysio-Control, Inc.20130Class I
+3K120188ElectrocardiographEdan Instruments, Inc.20120—
+3K111805Ecg Series ElectrocardiographAdvanced Instrumentations, Inc.20110—
+3K103567Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc.20114—
+3K102830ElectrocardiographEdan Instruments, Inc.20109—
+3K091513Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12…Edan Instruments, Inc.2009321
+3K082709Vicor PD2I Analyzer, Version 2.1Vicor Technologies, Inc.20081—
+3K073089Lifepak 20EPhysio-Control, Inc.200811
+3K062331Highpak-12Ad Elektronik GmbH20070—
+3K063119Lifepak 20 Defibrillator/ MonitorMedtronic Emergency Response Systems, Inc.200625
+3K033492Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies200331—
+3K033275Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp.2003201
+3K024283Cardiodirect, Models 12M, 12I, 12SReynolds Medical, Ltd.20034—
+4K240162LIFEPAK® 35 AC Power Adapter (41335-000001)Stryker Physio-Control20241—
+4K213699CareTaker Monitor AppCaretaker Medical, LLC20220—
+4K201914HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation20210—
+4K171943ElectrocardiographEdan Instruments, Inc.20171—
+4K160876PC ECGEdan Instruments, Inc.20178—
+4K141946Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20153—
+4K123148Parace MD Ekoscope IS100Parace, LLC20130—
+4K130207Spacelabs Healthcare CardioexpressSpacelabs Healthcare, Ltd.20130—
+4K101867Vicor PD2I AnalyzerVicor Technologies, Inc.20110—
+4K101876Digital Electrocardiograph, Models Ecg-1210, Ecg-1230, Ecg-3010, Ecg-6010Shenzhen Biocare Electronics Co., Ltd.201113—
+4K093211Carecenter MDCardiac Science Corporation20101—
+4K082380Vicardio 12BEnergy-Lab Technologies GmbH20080—
+4K062469Voyager 12Del Mar Reynolds Medical, Ltd.20060—
+4K052057Lifepak 500 Automated External DefibrillatorMedtronic Emergency Response Systems, Inc.200643
+4K042404Lifepak, Model 1000Medtronic Emergency Response Systems, Inc.200512
+4K042177Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies200430—
+5K253099LIFEPAK 15 AC Power Adapter (41577-000333)Physio-Control, Inc.20250—
+5K232816Electrocardiograph, model: ECG301Shenzhen LE Medical Technology Co., Ltd.20240—
+5K171942ElectrocardiographEdan Instruments, Inc.20183—
+5K171517Digital ElectrocardiographBiocare Bio-Medical Equipment Co., Ltd.20180—
+5K170995ElectrocardiographEdan Instruments, Inc.20173—
+5K160092Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20161—
+5K131858Digital ElectrocardiographGuangdong Biolight Meditech Co., Ltd.20140—
+5K123217CardeascreenCardea Associates, Inc.20130—
+5K122712Digital ElectrocardiographShenzhen Biocare Electronics Co., Ltd.20128—
+5K122600Lifepak 1000 DefibrillatorPhysio-Control, Inc.20120Class I
+5K113485ElectrocardiographShenzhen Carewell Electronics Co., Ltd.20123—
+5K112431Digital ElectrocardiographShenzhen Biocare Electronics Co., Ltd.20119—
+5K073625Modification to: Mac 5500 Resting Ecg Analysis SystemGe Healthcare Systems Information Technologies20087—
+5K072596Life+Cel or Lifecel Battery Pack, Model 5L500Amco International Manufacturing & Design, Inc.20080—
+5K052465Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251…Heartsine Technologies, Inc.20062Class I
+5K06083312SL Ecg Analysis ProgramGe Medical Systems Information Technologies200621—
+6K233266Mediblu Ecg SystemMediblu Medical, LLC20240—
+6K212278ElectrocardiographEdan Instruments, Inc.20222—
+6K220362LE-12CHCaf Medical Solutions, Inc.20220—
+6K210140electrocardiograph: SE-1202Edan Instruments, Inc.20211—
+6K180432AI-ECG PlatformShenzhen Carewell Electronics., Ltd.20180—
+6K142288MAC 800 Resting ECG Analysis SystemGe Medical Systems China Co., Ltd.20140—
+6K131900Contec ElectrocardiographContec Medical System Co., Ltd.20141—
+6K132758Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20141—
+6K133622Mac 2000 Ecg Analysis SystemWipro GE Healthcare20141—
+6K131262Digital ElectrocardiographsSonoscape Company Limited20130—
+6K123881Heartsine Samaritan Pad 350PHeartsine Technologies, Inc.201311
+6K123816Digital ElectrocardiographsShenzhen Biocare Electronics Co., Ltd.20134—
+6K103765Mac 600 Resting Ecg Analysis SystemGe Medical Systems Information Technologies, Inc.20110—
+6K110266Mac 5500 HD, Mac 3500Ge Medical Systems Information Technologies, Inc.20111—
+6K09236912SL Ecg Analysis ProgramGe Medical Systems Information Technologies201019—
+6K093172Quantitative Electrocardiographic Detector (Qed 1000)Dynacardia, Inc.20100—
+6K092663Eli 350 ElectrocardiographMortara Instrument, Inc.200901
+7K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.20260—
+7K230834CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800HTrismed Co., Ltd.20230—
+7K222902Electrocardiograph: SE-1200 Pro and SE-1201 ProEdan Instruments, Inc.20231—
+7K171360CONTEC™ ElectrocardiographContec Medical Systems Co.,Ltd20180—
+7K162012CARESCAPE Central Station V2GE Healthcare201676
+7K152135Quantitative Electrocardiographic Detector (QED 2000)Acme Portable Machines, Inc.20160—
+7K142709samaritan PAD 450PHeartsine Technologies, Inc.20150—
+7K14196312SL Ecg Analysis ProgramGe Medical Systems Information Technologies, Inc.20156—
+7K133985Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20151—
+7K133882Carescape Central Station (Formally Known as Cic Pro)Ge Medical Systems Information Technologies, Inc.201491
+7K103791Physioglove ES with Ecg AnalysisCommwell, Ltd.20111—
+8K231010CorvairAliveCor, Inc.20241—
+8K232210X-trodes System MX-Trodes20240—