510(k) Report

Devices descending from K012466

305 later devices reach Bis/Eeg Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K081983M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems200883
+6K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086—
+6K071800Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN200774
+6K072070Philips MP2 and X2 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007119—
+6K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007175—
+6K062137Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200682
+7K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+7K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+7K240558NavoycdsAlgodx AB20240—
+7K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+7K231035FusedCO AlgorithmEdwards Lifesciences, LLC20230—
+7K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+7K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+7K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+7K220111RespiraSensePmd Solutions20221—
+7K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+7K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+7K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+7K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+7K202306T3 Platform softwareEtiometry, Inc.202013—
+7K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+7K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+7K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+7K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC20202—
+7K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+7K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+7K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+7K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+7K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+7K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+7K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+7K172226MX40 Release B.07Philips Medical Systems201713—
+7K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+7K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+7K171322eCareManager 4.1Visicu, Inc.20172—
+7K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+7K160981Patient MonitorEdan Instruments, Inc.201681
+7K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+7K153335AlertWatch: ORAlertwatch, LLC20161—
+7K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+7K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+7K142106Decisio Health Patient DashboardDecisio Health, Inc.20155—
+7K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+7K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems201441
+7K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+7K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+7K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc.20141—
+7K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+7K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+7K131032Philips Suresigns CentralPhilips Medical Systems20131—
+7K130170Exspiron 1XIRespiratory Motion, Inc.20134—
+7K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+7K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+7K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+7K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH20112—
+7K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+7K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH20104—
+7K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+7K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+8K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+8K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+8K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+8K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+8K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+8K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20241—
+8K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+8K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+8K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+8K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+8K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+8K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+8K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+8K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+8K213230T3 Platform SoftwareEtiometry, Inc.202212—
+8K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+8K211046eCareManager 4.5Visicu, Inc.20220—
+8K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+8K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+8K210160AlertWatch:ACAlertwatch, Inc.20210—
+8K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+8K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+8K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+8K192514Patient MonitorEdan Instruments, Inc.202061
+8K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+8K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+8K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+8K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+8K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+8K180017MX40 Release C.01Philips Medical Systems20181—
+8K173715AlertWatch:OBAlertwatch, Inc.20180—
+8K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+8K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+8K161056Telemetry TransmitterEdan Instruments, Inc.201702
+8K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+8K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+8K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+8K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+8K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+8K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+8K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—