510(k) Report

Devices descending from K963644

340 later devices reach A-1000 Eeg Monitor and a-1050 Eeg Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K230386SpassageQSpass, Inc.20231—
+8K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+8K190273T3 Platform softwareEtiometry, Inc.201914—
+8K183370PeraMobile and PeraWatchPerahealth, Inc.20190—
+8K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC201840—
+8K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+8K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+8K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+8K153156eCareManager 4.0.1Visicu, Inc.20163—
+8K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+8K152552Patient MonitorEdan Instruments, Inc.201621
+8K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328
+8K150512STAR 90Skanray Technologies Pvt, Ltd.20151—
+8K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+8K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+8K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America201410—
+8K130401Alertwatch: orAlertwatch, LLC20148—
+8K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+8K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+8K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+8K120087ExspironRespiratory Motion, Inc.20128—
+8K120631Patient MonitorAdvanced Instruments, Inc.20120—
+8K120173Patient MonitorEdan Instruments, Inc.201210—
+8K113653Patient MonitorEdan Instruments, Inc.201212
+8K113623Patient MonitorEdan Instruments, Inc.2012152
+8K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+8K111083Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201111
+8K110809Wireless Monitoring SystemCarefusion 303, Inc.20112—
+8K103646Intellivue MX40 Patient MonitorPhillips Medical Systems2011161
+8K102495M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems201077
+8K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+8K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201092—
+8K092028Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH20103—
+8K091395MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200984—
+8K083750Capnostat / Capnoflex CO2 SystemGe Medical Systems Information Technologies20090—
+8K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Philips Medizin Systeme Boeblingen GmbH2008143—
+8K081983M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems200883
+8K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086—
+8K071800Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN200774
+8K072070Philips MP2 and X2 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007119—
+8K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007175—
+8K062137Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200682
+9K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+9K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+9K240558NavoycdsAlgodx AB20240—
+9K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+9K231035FusedCO AlgorithmEdwards Lifesciences, LLC20230—
+9K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+9K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+9K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+9K220111RespiraSensePmd Solutions20221—
+9K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+9K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+9K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+9K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+9K202306T3 Platform softwareEtiometry, Inc.202013—
+9K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+9K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+9K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC20202—
+9K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+9K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+9K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+9K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+9K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+9K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+9K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+9K172226MX40 Release B.07Philips Medical Systems201713—
+9K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+9K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+9K171322eCareManager 4.1Visicu, Inc.20172—
+9K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+9K160981Patient MonitorEdan Instruments, Inc.201681
+9K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+9K153335AlertWatch: ORAlertwatch, LLC20161—
+9K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+9K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+9K142106Decisio Health Patient DashboardDecisio Health, Inc.20155—
+9K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+9K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems201441
+9K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+9K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+9K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc.20141—
+9K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+9K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+9K131032Philips Suresigns CentralPhilips Medical Systems20131—
+9K130170Exspiron 1XIRespiratory Motion, Inc.20134—
+9K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+9K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+9K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+9K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH20112—
+9K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+9K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH20104—
+9K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+9K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+10K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+10K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+10K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+10K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+10K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+10K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20241—