510(k) Report

Devices descending from K993036

304 later devices reach Zoll M Series ETCO2 Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042007Zoll E Series DefibrillatorZoll Medical Corp2005643
+1K042417Zoll M Series ETC02 Loflo OptionZoll Medical Corp2004238—
+2K110168Zoll E Series with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters201115—
+2K091265Zoll E Series with CprreadychargeZoll Medical Corporation, World Wide Headquarters20090—
+2K092598Zoll E Series with Spco/Spmet OptionZoll Medical Corporation, World Wide Headquarters20092—
+2K090989Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp200927—
+2K090801Electronic House CallExpress MD Solutions, LLC20093—
+2K081081Zoll E Series with Bluetooth Dial UP NetworkingZoll Medical Corporation, World Wide Headquarters20090—
+2K080903Zoll E Series with Intibation Assist OptionZOLL Medical Corporation20083—
+2K080232Zoll E Series 12SL, Analysis OptionZoll Medical Corporation, World Wide Headquarters20080—
+2K060559Zoll R Series DefibrillatorZOLL Medical Corporation2006211
+2K053174Loflo C5 CO2 SensorRespironics Novametrix, LLC20062372
+3K192488CO2 Sidestream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20200—
+3K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+3K142244Cleo Patient MonitorInfinium Medical201501
+3K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+3K140502Zoll E Series AlsZOLL Medical Corporation20141—
+3K131586Canary Breathing SystemPalo Alto Health Sciences, Inc.20132—
+3K123797NT1D Vital Signs MonitorNew Tech, Inc.20130—
+3K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+3K122839Zoll Surepower Single Bay ChargerZOLL Medical Corporation20120—
+3K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+3K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+3K102063Health-E-Connect SystemAlr Technologies20111—
+3K111594Zoll E SeriesZoll Medical Corporation, World Wide Headquarters201110—
+3K110742Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation201191
+3K100654Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201011—
+3K093895Ally Platform SystemContinuity Health Solutions20100—
+3K081828Zoll R Series BLS DefibrillatorZOLL Medical Corporation20088—
+3K081574Zoll R SeriesZOLL Medical Corporation20088—
+3K062095Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.20063—
+3K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006222—
+4K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+4K180173FreespiraPalo Alto Health Sciences, Inc.20181—
+4K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+4K163664Health-e-Connect System with IDAAlr Technologies20170—
+4K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+4K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+4K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+4K150198CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelBio-Detek, Inc.20150—
+4K133239Zoll E SeriesZoll Medical Corporation, World Wide Headquarters20150—
+4K133441Onestep CPR II Multi-Function ElectrodeBio-Detek, Inc.20141—
+4K133484Zoll X SeriesZoll Medical Corp20141—
+4K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+4K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+4K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+4K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters20126—
+4K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+4K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+4K121367Zoll Propaq XMZOLL Medical Corporation201231
+4K112761Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201201
+4K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH201281—
+4K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2012781
+4K112190Patient MonitorMediana Co., Ltd.20110—
+4K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2011902
+4K110361Zoll R Series with 2010 Aha Guidelines Software UpdateZoll Medical Corporation, World Wide Headquarters20117—
+4K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boblingen GmbH2010103—
+4K102468Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters20109—
+4K100217Lucon M-Series Patient Monitor, Models M20 and M30Mediana Co., Ltd.20101—
+4K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009124—
+4K082583Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009945
+4K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20091252
+4K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20081273
+4K082045Modification to Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.200801
+4K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007151—
+4K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90Philips Medizin Systeme Boeblingen GmbH2006154—
+4K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc.2006188—
+4K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2006176—
+4K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006155—
+4K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc.2006211—
+4K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH20062212
+5K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+5K222101PrismGraymatters Health, Ltd.20230—
+5K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+5K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+5K191882Masimo Centroid SystemMasimo Corporation20203—
+5K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+5K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+5K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+5K180482ZOLL Propaq MZOLL Medical Corporation20182—
+5K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC201840—
+5K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+5K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH20177—
+5K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+5K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+5K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+5K153156eCareManager 4.0.1Visicu, Inc.20163—
+5K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+5K152552Patient MonitorEdan Instruments, Inc.201621
+5K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328
+5K150055OneStep Pediatric CPR Multi-Function ElectrodeBio-Detek, Inc.20150—
+5K142915ZOLL X SeriesZOLL Medical Corporation20140—
+5K141774Zoll X SeriesZOLL Medical Corporation20142—
+5K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+5K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+5K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America201410—
+5K130401Alertwatch: orAlertwatch, LLC20148—
+5K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+5K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+5K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—