510(k) Report

Devices descending from K961139

121 later devices reach Eagle Patient Monitor Model 3000/3100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993531Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp.20001191
+1K973984Rac 2A Module HousingMarquette Medical Systems, Inc.19980—
+2K052544Pulse Oximeter Adapter CablesAmerican I.V. Products, Inc.20060—
+2K041907Trio MonitorDatascope Corp.20040—
+2K032733PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd.200488—
+2K020550Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp.2002751
+3K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+3K090443Planet 55, Model 100Larsen & Toubro Limited20090—
+3K070791PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd.200747—
+3K062144Escort M8 Vital Signs Patient Monitor, Model 3810Invivo Corporation200611—
+3K043348Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200587—
+3K031849Spectrum Patient Monitor, Model 0998-00-0500-XxxxxDatascope Corp.200391
+4K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+4K112877Comen Multi-Parameter Patient MonitorGoldway (Us), Inc.20121—
+4K091834Passport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division200902
+4K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO2009101
+4K082887PM-1000F+Patient MonitorAdvanced Instrumentations, Inc.20090—
+4K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+4K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+4K072346PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200719—
+4K062098Spectrum Monitor, Model 0998-00-1000-XxxxxDatascope Corp.20077—
+4K063055VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200613—
+4K060281VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200616—
+4K053193PM-8000 Express Patient Monitor, Model PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd.200648—
+4K053234PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006711
+5K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+5K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+5K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+5K132229Omni Patent MonitorsInfinium Medical20142—
+5K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+5K130740Nightingale Monitoring SystemZoe Medical, Inc.20133—
+5K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc.201321
+5K110922Patient MonitorEdan Instruments, Inc.201111
+5K101692Patient MonitorContec Medical System Co., Ltd.201101
+5K102004Endeavour Monitoring SystemMindray DS USA, Inc.201033
+5K100740MD2000B Vital Sign Monitor, Model MD2000BBeijing Choice Electronic Technololgy Co., Ltd.20102—
+5K101127Patient Monitor, Model PM50Contec Medical System Co., Ltd.20100—
+5K100394Multi-Parameter Patient Monitor, Model# PMS8210AShanghai 3f Electronics Co, Ltd.20101—
+5K093802Ultraview DM3 MonitorZoe Medical, Inc.201002
+5K100046M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd.201016—
+5K092970General Patient Monitors, Models: G3C/ G3D/ G3F/ G3G/ G3HGeneral Meditech, Inc.20100—
+5K092727H100B Pulse OximeterEdan Instruments, Inc.20090—
+5K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc.200912
+5K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+5K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+5K082787Vital Signs Monitor, Model: MD500BBeijing Choice Electronic Technololgy Co., Ltd.20090—
+5K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+5K080173STAR 55Larsen & Toubro Limited20085—
+5K072235PM-50 Pulse Oximeter and VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200772
+6K211754Vital Signs MonitorBeijing Choice Electronic Technology Co., Ltd.20210—
+6K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+6K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+6K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+6K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+6K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+6K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+6K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+6K152043Diagnostic Station DS20Schiller AG20161—
+6K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+6K153079Axeo 3 Patient MonitorAxeo Medical Technologies, LLC20160—
+6K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+6K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+6K150620740 SelectCas Medical Systems, Inc.201501
+6K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+6K142244Cleo Patient MonitorInfinium Medical201501
+6K131762Handheld MonitorGuangdong Biolight Meditech Co., Ltd.20147—
+6K132037Vital Signs MonitorMindray North America201432
+6K132038Accutorr 7 Vital Signs MonitorMindray North America20142—
+6K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+6K132026V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21Mindray DS USA, Inc.201321
+6K131763Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd.20130—
+6K130056Patient MonitorLd Technology, LLC20130—
+6K120631Patient MonitorAdvanced Instruments, Inc.20120—
+6K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+6K113183PMS8210A (Iris) Multi-Parameter Patient Monitor, Model Code 500Shanghai 3f Electronics Co, Ltd.20120—
+6K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+6K112803Patient MonitorGuangdong Biolight Meditech Co., Ltd.20110—
+6K103686STAR 50 NLarsen & Toubro Limited20111—
+6K102040Patient MonitorGuangdong Biolight Meditech Co., Ltd.20101—
+6K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+6K090172Star 55 Model 100Larsen & Toubro Limited20090—
+6K082685Galaxy 55Larsen & Toubro Limited20080—
+7K253436c-med0 alphaCosinuss GmbH20260—
+7K232111NeoBeat, NeoBeat MiniLaerdal Medical AS20240—
+7K231625VitalDetectWellvii, Inc.20240—
+7K221113Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+7K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+7K202892Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc.202111
+7K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+7K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+7K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+7K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+7K170712Accutorr 7/VS-900 Vital Signs MonitorShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201711
+7K170182Cardiovit FT-1Schiller AG20170—
+7K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+7K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+7K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+7K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+7K132033BM3/BM3 PlusNoblitt & Rueland20130—
+8K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—