510(k) Report

Devices descending from K001359

302 later devices reach Dash 3000/4000 Patient Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020290Dash 3000/4000 Patient MonitorGeneral Electric Medical Systems Information Techn20022841
+1K012915Dinamap Pro 1000 Monitor, Model 1000Ge Medical Systems Information Technologies2002271
+2K031376Dinamap Pro 1000 V3 Monitor, Model 1100 SeriesGe Medical Systems Information Technologies20032—
+2K022834Dinamap Pro 1000 Monitor with Superstat, Model 1000Ge Medical Systems Information Technologies200323—
+2K031320EK-Pro Arrhythmia Detection AlgorithmGe Medical Systems Information Technologies200342—
+2K030431Modification to Dash 3000/4000 Patient MonitorGe Medical Systems Information Technologies20032571
+3K170155EK12 AlgorithmGe Medical Systems Information Technologies, Inc.20171—
+3K102239Carescape Monitor B650GE Healthcare Finland Oy2010328
+3K083750Capnostat / Capnoflex CO2 SystemGe Medical Systems Information Technologies20090—
+3K080157Dash 2500 Patient MonitorGe Medical Systems Information Technologies20081—
+3K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086—
+3K073203Carescape V100Ge Medical Systems Information Technologies200720—
+3K050583Model 250 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies20051—
+3K042417Zoll M Series ETC02 Loflo OptionZoll Medical Corp2004238—
+3K033304Modification to Dash 3000/4000 Patient MonitorGe Medical Systems Information Technologies2003121
+3K031849Spectrum Patient Monitor, Model 0998-00-0500-XxxxxDatascope Corp.200391
+4K221904EK12 V2 AlgorithmGe Medical Systems Information Technologies, Inc.20220—
+4K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd.201741
+4K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+4K132533Carescape Monitor B450GE Healthcare Finland Oy2013143
+4K131223Carescape Monitor B650GE Healthcare Finland Oy2013134
+4K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+4K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+4K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies201011—
+4K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+4K091834Passport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division200902
+4K090702Modification to Dash 2500 Patient MonitorGe Medical Systems Information Technologies20090—
+4K072976Model 250CX Series Maternal/Fetal MonitorGE Healthcare20070—
+4K062098Spectrum Monitor, Model 0998-00-1000-XxxxxDatascope Corp.20077—
+4K052544Pulse Oximeter Adapter CablesAmerican I.V. Products, Inc.20060—
+4K053174Loflo C5 CO2 SensorRespironics Novametrix, LLC20062372
+4K051367Patient Monitor, Models Dash 3000, 4000 and 5000Ge Medical Systems Information Technologies200591
+4K040458Modification to Dash 3000/4000 Patient MonitorGe Medical Systems Information Technologies200401
+5K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+5K192488CO2 Sidestream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20200—
+5K191249Carescape B450GE Healthcare Finland Oy20204—
+5K191149Carescape B650GE Healthcare Finland Oy202072
+5K190008Carescape OneGE Healthcare201911—
+5K152659V10Mediana Co., Ltd.20162—
+5K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+5K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+5K151071SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20153—
+5K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+5K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+5K142244Cleo Patient MonitorInfinium Medical201501
+5K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+5K132229Omni Patent MonitorsInfinium Medical20142—
+5K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+5K131586Canary Breathing SystemPalo Alto Health Sciences, Inc.20132—
+5K123797NT1D Vital Signs MonitorNew Tech, Inc.20130—
+5K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302
+5K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+5K102004Endeavour Monitoring SystemMindray DS USA, Inc.201033
+5K073462Modification to Dash 3000, 4000, 5000 Monitor and AccessoriesGe Medical Systems Information Technologies200889
+5K062095Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.20063—
+5K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006222—
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+6K213181CARESCAPE B650, E-musbGE Healthcare Finland Oy202262
+6K213363CARESCAPE B450, E-musbGE Healthcare Finland Oy202211
+6K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+6K200494CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRESGE Healthcare2020101
+6K180173FreespiraPalo Alto Health Sciences, Inc.20181—
+6K170497V10Mediana Co., Ltd.201711
+6K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring…Capsule Technologie Sas20172—
+6K153079Axeo 3 Patient MonitorAxeo Medical Technologies, LLC20160—
+6K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+6K151063Monitor B40Ge Medical Systems China Co., Ltd.201551
+6K143676B40i Patient MonitorGE Healthcare Finland Oy201541
+6K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+6K132026V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21Mindray DS USA, Inc.201321
+6K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+6K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+6K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+6K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+6K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH201281—
+6K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2012781
+6K112190Patient MonitorMediana Co., Ltd.20110—
+6K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2011902
+6K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boblingen GmbH2010103—
+6K100217Lucon M-Series Patient Monitor, Models M20 and M30Mediana Co., Ltd.20101—
+6K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009124—
+6K082583Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009945
+6K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20091252
+6K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20081273
+6K082045Modification to Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.200801
+6K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007151—
+6K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90Philips Medizin Systeme Boeblingen GmbH2006154—
+6K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc.2006188—
+6K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2006176—
+6K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006155—
+6K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc.2006211—
+6K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH20062212
+7K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+7K230579Smart Wedge algorithmEdwards Lifesciences, LLC20235—
+7K223498Radius VSM and AccessoriesMasimo Corporation202312
+7K222101PrismGraymatters Health, Ltd.20230—
+7K213234CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG…Ge Medical Systems Information Technologies, Inc.202231
+7K212876Carescape SpO2 - MasimoMasimo Corporation20212—
+7K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+7K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001