510(k) Report

Devices descending from K000822

462 later devices reach Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi-Measurement… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boblingen GmbH2004251—
+3K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004252—
+3K040357M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry…Philips Medical Systems, Inc.2004260—
+3K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004253—
+3K033715Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement ServerPhilips Medical Systems, Inc.20041863
+3K033444Philips Medical Systems, M3012A- Hemodynamic Extension to the Multi-Measurement ServerPhilips Medical Systems2003156—
+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—
+3K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient…Philips Medical Systems2002406—
+4K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+4K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+4K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+4K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+4K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+4K200069Disposable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20200—
+4K192608Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd20200—
+4K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+4K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC201840—
+4K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+4K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH20177—
+4K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+4K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+4K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+4K160981Patient MonitorEdan Instruments, Inc.201681
+4K153156eCareManager 4.0.1Visicu, Inc.20163—
+4K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+4K152552Patient MonitorEdan Instruments, Inc.201621
+4K152831Spot SkanSkanray Technologies Private Limited20160—
+4K151512Star 60Skanray Technologies Private Limited20160—
+4K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+4K150512STAR 90Skanray Technologies Pvt, Ltd.20151—
+4K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+4K132516Oxiprobe E (Oxiprobe)Bio Medical Technologies Co., Ltd.20140—
+4K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+4K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America201410—
+4K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+4K130401Alertwatch: orAlertwatch, LLC20148—
+4K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+4K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+4K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+4K120087ExspironRespiratory Motion, Inc.20128—
+4K112190Patient MonitorMediana Co., Ltd.20110—
+4K112652Suresigns VS2+ -Suresigns VsiPhilips Medical Systems201103
+4K111083Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201111
+4K110809Wireless Monitoring SystemCarefusion 303, Inc.20112—
+4K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH20112—
+4K110287Philips Ecg Leadwire SetPhilips Medical Systems201151
+4K103646Intellivue MX40 Patient MonitorPhillips Medical Systems2011161
+4K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG2010312
+4K101133Sensometrics SoftwareDpcom AS20100—
+4K102495M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems201077
+4K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+4K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH20104—
+4K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+4K091395MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200984—
+4K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+4K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Philips Medizin Systeme Boeblingen GmbH2008143—
+4K081983M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems200883
+4K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086—
+4K072070Philips MP2 and X2 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007119—
+4K070791PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd.200747—
+4K062271M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150…Philips Medical Systems200693
+4K053234PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006711
+4K050919Lifegard II Family Multi-Function Patient Monitor, Models AN4320, AN4320P, AN4321P…Analogic Corp.20050—
+4K041741M3290A Intellivue Information Center Software Release F.0 and M4840A Philips Telemetry…Philips Medical Systems, Inc.20041554
+4K040955M3290A Intellivue Information Center Software Release E.01 and Intellivue Clinical…Philips Medical Systems, Inc.200410—
+4K040259Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp.2004312—
+4K033513Easi Ecg AlgorithmPhilips Medical Systems2004220—
+5K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+5K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+5K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG20240—
+5K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+5K231035FusedCO AlgorithmEdwards Lifesciences, LLC20230—
+5K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+5K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+5K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+5K220111RespiraSensePmd Solutions20221—
+5K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+5K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+5K212876Carescape SpO2 - MasimoMasimo Corporation20212—
+5K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+5K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+5K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+5K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+5K192514Patient MonitorEdan Instruments, Inc.202061
+5K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC20202—
+5K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+5K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+5K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+5K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+5K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+5K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+5K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+5K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+5K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+5K172226MX40 Release B.07Philips Medical Systems201713—
+5K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+5K171322eCareManager 4.1Visicu, Inc.20172—
+5K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—