510(k) Report

Devices descending from K032858

375 later devices reach The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+3K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+3K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC20202—
+3K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+3K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+3K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+3K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+3K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+3K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+3K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+3K173952Universal SmartECGVectracor, Inc.20181—
+3K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+3K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+3K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+3K171322eCareManager 4.1Visicu, Inc.20172—
+3K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+3K160981Patient MonitorEdan Instruments, Inc.201681
+3K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+3K153335AlertWatch: ORAlertwatch, LLC20161—
+3K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+3K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+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—
+3K142106Decisio Health Patient DashboardDecisio Health, Inc.20155—
+3K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+3K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems201441
+3K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+3K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+3K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc.20141—
+3K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+3K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+3K131032Philips Suresigns CentralPhilips Medical Systems20131—
+3K130170Exspiron 1XIRespiratory Motion, Inc.20134—
+3K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+3K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+3K110922Patient MonitorEdan Instruments, Inc.201111
+3K101692Patient MonitorContec Medical System Co., Ltd.201101
+3K102560Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20110—
+3K103646Intellivue MX40 Patient MonitorPhillips Medical Systems2011161
+3K101280Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeMidwest Reprocessing Center, LLC20100—
+3K100046M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd.201016—
+3K092028Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH20103—
+3K092970General Patient Monitors, Models: G3C/ G3D/ G3F/ G3G/ G3HGeneral Meditech, Inc.20100—
+3K092727H100B Pulse OximeterEdan Instruments, Inc.20090—
+3K092368Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20090—
+3K083719LNCS Oximetry SensorsMasimo Corporation20092—
+3K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+3K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+3K083622LNCS Oximetry SensorsMasimo Corporation20091—
+3K082888Infinity Nellcor Oximax Smartpod, Model MS23997Draeger Medical Systems, Inc.20080—
+3K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Philips Medizin Systeme Boeblingen GmbH2008143—
+3K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+3K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+3K081238Reprocessed Masimo Pulse Oximeter SensorsAscent Healthcare Solutions20083—
+3K080424Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and…Hygia Health Services, Inc.20081—
+3K071800Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN200774
+3K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007175—
+3K062137Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200682
+3K060143LNCS and SPO2.Com SensorsMasimo Corporation200610—
+3K051212Modification to LNCS Oximetry SensorsMasimo Corporation2005855
+4K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+4K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+4K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+4K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+4K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+4K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20241—
+4K232035ImpalaAliveCor, Inc.20240—
+4K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+4K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+4K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+4K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+4K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+4K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+4K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+4K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+4K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+4K211046eCareManager 4.5Visicu, Inc.20220—
+4K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+4K211140Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse…Stryker Sustainability Solutions20222—
+4K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+4K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+4K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+4K210160AlertWatch:ACAlertwatch, Inc.20210—
+4K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+4K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+4K192514Patient MonitorEdan Instruments, Inc.202061
+4K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+4K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+4K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+4K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+4K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+4K173715AlertWatch:OBAlertwatch, Inc.20180—
+4K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+4K172226MX40 Release B.07Philips Medical Systems201713—
+4K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+4K161056Telemetry TransmitterEdan Instruments, Inc.201702
+4K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+4K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+4K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+4K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—