510(k) Report

Devices descending from K971910

472 later devices reach Multi-Parameter Module (M3000A)/Display Unit (M3046A) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+3K150512STAR 90Skanray Technologies Pvt, Ltd.20151—
+3K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+3K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+3K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+3K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America201410—
+3K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+3K130401Alertwatch: orAlertwatch, LLC20148—
+3K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+3K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+3K120087ExspironRespiratory Motion, Inc.20128—
+3K120173Patient MonitorEdan Instruments, Inc.201210—
+3K120132Suresigns VS3 Vital Signs Monitor, Suresigns VS4 Vital Signs MonitorPhilips Medical Systems20126—
+3K113653Patient MonitorEdan Instruments, Inc.201212
+3K113623Patient MonitorEdan Instruments, Inc.2012152
+3K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+3K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+3K111083Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201111
+3K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+3K110809Wireless Monitoring SystemCarefusion 303, Inc.20112—
+3K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited20110—
+3K110803Suresigns Vsi Vital Signs MonitorPhilips Medical Systems20111—
+3K111114Suresigns VS2 Vital Signs MonitorPhilips Medical Systems20111—
+3K100077Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Solaris Medical Technology, Inc.201022—
+3K102495M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems201077
+3K102430Tyco Electronics Electrocardiograph (Ecg) Leadwire SetTyco Electronics Corporation20106—
+3K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201092—
+3K100217Lucon M-Series Patient Monitor, Models M20 and M30Mediana Co., Ltd.20101—
+3K092028Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH20103—
+3K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+3K091572Disposable SPO2 Sensor M1134APhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200938—
+3K081983M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems200883
+3K071800Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN200774
+3K063783Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor M1196T and…Philips Medical Systems, Inc.200741—
+3K062271M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150…Philips Medical Systems200693
+3K062137Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200682
+3K051366Piconibp Oem ModulePhilips Medizin Systeme Boeblingen GmbH200510—
+3K050919Lifegard II Family Multi-Function Patient Monitor, Models AN4320, AN4320P, AN4321P…Analogic Corp.20050—
+3K043463Envitec Reusable Multi-Site Y SPO2 SensorsEnvitec-Wismar GmbH20055—
+3K041741M3290A Intellivue Information Center Software Release F.0 and M4840A Philips Telemetry…Philips Medical Systems, Inc.20041554
+3K040955M3290A Intellivue Information Center Software Release E.01 and Intellivue Clinical…Philips Medical Systems, Inc.200410—
+3K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O.Philips Medizin Systeme Boblingen GmbH2003375—
+3K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003376—
+3K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185…Philips Medical Systems, Inc.2003404—
+4K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+4K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+4K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+4K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+4K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+4K231035FusedCO AlgorithmEdwards Lifesciences, LLC20230—
+4K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+4K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+4K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+4K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+4K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+4K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+4K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+4K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+4K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+4K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC20202—
+4K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+4K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+4K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+4K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+4K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+4K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+4K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+4K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+4K173368Reusable & Disposable SpO2 SensorsShenzhen Coreray Technology, Ltd.20180—
+4K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+4K180017MX40 Release C.01Philips Medical Systems20181—
+4K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+4K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+4K171322eCareManager 4.1Visicu, Inc.20172—
+4K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+4K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+4K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd.20175—
+4K160981Patient MonitorEdan Instruments, Inc.201681
+4K152390Medke Oximetry Finger SensorShenzhen Medke Technology Co., Ltd.20160—
+4K153335AlertWatch: ORAlertwatch, LLC20161—
+4K152831Spot SkanSkanray Technologies Private Limited20160—
+4K151512Star 60Skanray Technologies Private Limited20160—
+4K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+4K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.201514—
+4K142106Decisio Health Patient DashboardDecisio Health, Inc.20155—
+4K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+4K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems201441
+4K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+4K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+4K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc.20141—
+4K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+4K131032Philips Suresigns CentralPhilips Medical Systems20131—
+4K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+4K130170Exspiron 1XIRespiratory Motion, Inc.20134—
+4K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+4K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+4K121424Expression Information PortalInvivo Corporation201224
+4K112190Patient MonitorMediana Co., Ltd.20110—