510(k) Report

Devices descending from K952474

350 later devices reach Eagle 3000 Patient Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K192514Patient MonitorEdan Instruments, Inc.202061
+6K180902MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable AssemblyMedipines Corporation20190—
+6K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+6K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+6K170182Cardiovit FT-1Schiller AG20170—
+6K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+6K161056Telemetry TransmitterEdan Instruments, Inc.201702
+6K152552Patient MonitorEdan Instruments, Inc.201621
+6K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+6K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328
+6K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+6K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+6K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+6K133484Zoll X SeriesZoll Medical Corp20141—
+6K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+6K140430740 SelectCas Medical Systems, Inc.20141—
+6K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+6K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+6K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+6K132229Omni Patent MonitorsInfinium Medical20142—
+6K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+6K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+6K120984Masimo Ras-125C Acoustic Respiration SensorMasimo Corporation20132—
+6K123900Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems201352
+6K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+6K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+6K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201265—
+6K121367Zoll Propaq XMZOLL Medical Corporation201231
+6K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+6K101692Patient MonitorContec Medical System Co., Ltd.201101
+6K101995Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc.20117—
+6K102004Endeavour Monitoring SystemMindray DS USA, Inc.201033
+6K100740MD2000B Vital Sign Monitor, Model MD2000BBeijing Choice Electronic Technololgy Co., Ltd.20102—
+6K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation2010115—
+6K101127Patient Monitor, Model PM50Contec Medical System Co., Ltd.20100—
+6K100394Multi-Parameter Patient Monitor, Model# PMS8210AShanghai 3f Electronics Co, Ltd.20101—
+6K100046M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd.201016—
+6K092970General Patient Monitors, Models: G3C/ G3D/ G3F/ G3G/ G3HGeneral Meditech, Inc.20100—
+6K092727H100B Pulse OximeterEdan Instruments, Inc.20090—
+6K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+6K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+6K082787Vital Signs Monitor, Model: MD500BBeijing Choice Electronic Technololgy Co., Ltd.20090—
+6K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+6K072235PM-50 Pulse Oximeter and VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200772
+7K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+7K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+7K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+7K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+7K222330The Heart SeatCasana Care, Inc.20230—
+7K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+7K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+7K212975MedWandMedwand Solutions, Inc.20221—
+7K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+7K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+7K211754Vital Signs MonitorBeijing Choice Electronic Technology Co., Ltd.20210—
+7K202336Patient MonitorEdan Instruments, Inc.202131
+7K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+7K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+7K180482ZOLL Propaq MZOLL Medical Corporation20182—
+7K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+7K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation20180—
+7K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+7K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+7K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+7K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+7K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+7K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+7K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+7K153079Axeo 3 Patient MonitorAxeo Medical Technologies, LLC20160—
+7K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+7K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+7K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+7K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+7K142244Cleo Patient MonitorInfinium Medical201501
+7K142915ZOLL X SeriesZOLL Medical Corporation20140—
+7K141774Zoll X SeriesZOLL Medical Corporation20142—
+7K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+7K131762Handheld MonitorGuangdong Biolight Meditech Co., Ltd.20147—
+7K132037Vital Signs MonitorMindray North America201432
+7K132038Accutorr 7 Vital Signs MonitorMindray North America20142—
+7K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+7K132026V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21Mindray DS USA, Inc.201321
+7K132808Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc.20136—
+7K124041NBM-200MPOrsense, Ltd.20131—
+7K131763Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd.20130—
+7K130056Patient MonitorLd Technology, LLC20130—
+7K112368CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd.201266
+7K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+7K113183PMS8210A (Iris) Multi-Parameter Patient Monitor, Model Code 500Shanghai 3f Electronics Co, Ltd.20120—
+7K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+7K112803Patient MonitorGuangdong Biolight Meditech Co., Ltd.20110—
+7K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201167—
+7K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation201189—
+7K102040Patient MonitorGuangdong Biolight Meditech Co., Ltd.20101—
+7K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+8K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+8K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+8K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+8K232111NeoBeat, NeoBeat MiniLaerdal Medical AS20240—
+8K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401