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
+10K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+10K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+10K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+10K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+10K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+10K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+10K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+10K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+10K213230T3 Platform SoftwareEtiometry, Inc.202212—
+10K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+10K211046eCareManager 4.5Visicu, Inc.20220—
+10K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+10K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+10K210160AlertWatch:ACAlertwatch, Inc.20210—
+10K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+10K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+10K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+10K192514Patient MonitorEdan Instruments, Inc.202061
+10K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+10K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+10K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+10K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+10K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+10K180017MX40 Release C.01Philips Medical Systems20181—
+10K173715AlertWatch:OBAlertwatch, Inc.20180—
+10K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+10K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+10K161056Telemetry TransmitterEdan Instruments, Inc.201702
+10K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+10K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+10K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+10K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+10K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+10K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+10K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+10K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+11K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+11K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+11K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+11K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+11K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+11K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+11K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+11K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+11K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+11K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+11K240756Aitrics-VCAitrics Co., Ltd.20240—
+11K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+11K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+11K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+11K233216CLEWICU SystemClew Medical, Ltd.20240—
+11K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+11K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+11K223578T3 Platform softwareEtiometry, Inc.20232—
+11K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+11K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+11K213423T3 Platform softwareEtiometry, Inc.20232—
+11K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+11K222463EchoGo Heart FailureUltromics Limited20227—
+11K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+11K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+11K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+11K220732Mural Perinatal SurveillanceGe Medical Systems Information Technologies, Inc.20220—
+11K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+11K212219AHI SystemFifth Eye, Inc.20211—
+11K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+11K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+11K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+11K202336Patient MonitorEdan Instruments, Inc.202131
+11K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+11K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+11K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+11K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+11K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+11K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems20172—
+11K160746CARDIOLINE touchECGCardioline S.P.A20160—
+11K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+11K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+11K121424Expression Information PortalInvivo Corporation201224
+11K103700Essential Mri Patient MonitorInvivo Corporation20110—
+12K260008Deterioration Index Version 2Epic Systems Corporation20260—
+12K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+12K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+12K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+12K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+12K251293CardioVisionIcardio.Ai20250—
+12K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+12K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+12K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+12K241479Etiometry Platform (DAV 5.4 RAE 9.2)Etiometry, Inc.20251—
+12K240860EchoGo Amyloidosis (1.0)Ultromics Limited20242—
+12K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+12K240013EchoGo Heart Failure (2.0)Ultromics Limited20240—
+12K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+12K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+12K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+12K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+12K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+12K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+12K230842SignalHF (IM008)Implicity, Inc.20230—