510(k) Report

Devices descending from K955642

817 later devices reach Nellcor Symphony N-3000 Patient Monitor W/SP02 & Ecg/N-3200 Display/Printer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+6K212473Welch Allyn Connex Central StationWelch Allyn, Inc.20220—
+6K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+6K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+6K211365Alio Medical Remote Monitoring SystemGraftworx, Inc. Dba Alio20223—
+6K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+6K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102…Shenzhen Narig Bio-Medical Technology Co., Ltd.20221—
+6K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+6K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+6K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+6K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+6K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+6K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+6K201179GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableCovidien, LLC20200—
+6K200690LifeSignals ECG Remote Monitoring Patch PlatformLifesignals, Inc.20201—
+6K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+6K192488CO2 Sidestream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20200—
+6K192514Patient MonitorEdan Instruments, Inc.202061
+6K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+6K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co., Ltd.20190—
+6K192584BEACON Caresystem Model 00002144Mermaid Care A/S20190—
+6K190273T3 Platform softwareEtiometry, Inc.201914—
+6K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+6K183370PeraMobile and PeraWatchPerahealth, Inc.20190—
+6K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+6K190792BB-613WPBiobeat Technologies, Ltd.201912—
+6K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+6K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+6K183322physIQ Heart Rhythm and Respiratory ModulePhysiq, Inc.20191—
+6K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+6K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+6K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorNihon Kohden Corporation20190—
+6K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+6K181352Loop SystemSpry Health, Inc.201910—
+6K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+6K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+6K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+6K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC20181—
+6K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+6K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+6K180734SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie20180—
+6K172011LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc.20181—
+6K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+6K173510BioStamp nPointMc10, Inc.20180—
+6K172329Patient Status EngineIsansys Lifecare, Ltd.201810—
+6K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+6K172890SedLine Sedation MonitorMasimo Corporation20185—
+6K171836EarlySense Bed Sensing UnitEarlysense, Ltd.20180—
+6K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH20177—
+6K170497V10Mediana Co., Ltd.201711
+6K163453VitalPatch® VitalConnect PlatformVitalconnect, Inc.201711—
+6K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+6K163664Health-e-Connect System with IDAAlr Technologies20170—
+6K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+6K171244PhysiotraceNimbleheart, Inc.20170—
+6K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+6K170973VitalWatch Software User InterfaceVitalconnect, Inc.20171—
+6K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs…Caretaker Medical, LLC201715—
+6K161056Telemetry TransmitterEdan Instruments, Inc.201702
+6K153156eCareManager 4.0.1Visicu, Inc.20163—
+6K160526Masimo O3 Regional Oximeter SystemMasimo Corporation20165—
+6K152911EarlySense Insight SytemEarlysense, Ltd.20165—
+6K152552Patient MonitorEdan Instruments, Inc.201621
+6K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+6K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+6K150268CerOXOr-Nim Medical, Ltd.20150—
+6K151071SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20153—
+6K150512STAR 90Skanray Technologies Pvt, Ltd.20151—
+6K143675FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc.2015371
+6K134046Fukuda Denshi Dynascope Model DS-8100N/8100M Patient MonitorFukuda Denshi USA, Inc.201502
+6K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+6K143751Visi Mobile Monitoring SystemSotera Wireless, Inc.201517—
+6K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.201413
+6K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+6K140502Zoll E Series AlsZOLL Medical Corporation20141—
+6K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+6K133484Zoll X SeriesZoll Medical Corp20141—
+6K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+6K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America201410—
+6K130401Alertwatch: orAlertwatch, LLC20148—
+6K131085Central Venous Pressure System - Mespere Venus 1000Mespere Lifesciences, Inc.20131—
+6K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+6K122763Physiological Data ProcessorZephyr Technology Corporation20130—
+6K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+6K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302
+6K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+6K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+6K122839Zoll Surepower Single Bay ChargerZOLL Medical Corporation20120—
+6K120087ExspironRespiratory Motion, Inc.20128—
+6K121367Zoll Propaq XMZOLL Medical Corporation201231
+6K120631Patient MonitorAdvanced Instruments, Inc.20120—
+6K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+6K111083Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201111
+6K111594Zoll E SeriesZoll Medical Corporation, World Wide Headquarters201110—
+6K110742Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation201191
+6K103646Intellivue MX40 Patient MonitorPhillips Medical Systems2011161
+6K102495M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems201077
+6K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+6K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201092—
+6K101445Vital Signs Monitor-VSM 6000 SeriesWelch Allyn, Inc.201073—