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
+4K090697Modification to: Giraffe and Panda WarmerOhmeda Medical20091Class I
+4K090801Electronic House CallExpress MD Solutions, LLC20093—
+4K083325N-600X with SPD, Oximax N-600XCovidien200953—
+4K082599Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I, 500ATCnsystem Medizintechnik AG200825—
+4K081891Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc.20083—
+4K081238Reprocessed Masimo Pulse Oximeter SensorsAscent Healthcare Solutions20083—
+4K080652Mercury VCO2 Module with Capnostat 5Respironics Novametrix, LLC200814
+4K071642Mediaid M960 Series, Vital Signs Monitor and Mediaid M900 Series, Pulse OximeterMediaid, Inc.20080—
+4K073407PacificaOr-Nim Medical, Ltd.20081—
+4K073462Modification to Dash 3000, 4000, 5000 Monitor and AccessoriesGe Medical Systems Information Technologies200889
+4K072976Model 250CX Series Maternal/Fetal MonitorGE Healthcare20070—
+4K073203Carescape V100Ge Medical Systems Information Technologies200720—
+4K072516Midmark Diagnostics Iqmark Vital Signs MonitorMidmark Diagnostics Group20072—
+4K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc.2007197—
+4K071606Biosign Central StationObs Medical20070—
+4K072157Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)Ohmeda Medical200721
+4K063814BP-200 PlusSchiller AG20077—
+4K063087Modification to Model 750 Series MonitorCas Medical Systems, Inc.20060—
+4K060675Envitec Reusable Softip Y SPO2 SensorsEnvitec-Wismar GmbH20064—
+4K060820Cycle BP Monitor and Pulse Oximeter, Model 1060Suntech Medical, Inc.20062—
+4K061112Conmed PRO2 Pulse Reflectance Oximeter, Model Pro-MConmed Corporation20060—
+4K051907InnocorInnovision A/S20064—
+4K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Philips Medizin Systeme Boeblingen GmbH2006233—
+4K051352Oximax NPB-40 Handheld Pulse OximeterNellcor Puritan Bennett, Inc.200528—
+4K051375Vital Signs MonitorMediana Co., Ltd.20053—
+4K033028Anefin, Model 100Axon Medical20051—
+4K050605Spacelabs Medical Multiparameter Module 91496Spacelabs Medical, Inc.200511
+4K042007Zoll E Series DefibrillatorZoll Medical Corp2005643
+4K050068Lnopv AD-L and PD-L Oximetry SensorsMasimo Corporation20050—
+4K041644Flexi-Stat Disposable Non-Adhesive SPO2 Sensors, (Nellcor-Compatible), (Bci-Compatible)…Elekon Industries U.S.A., Inc.20040—
+4K041450Modification to Nico with Mars, Model 7300Respironics Novametrix, Inc.200401
+4K041412Esprit Ventilator with Nico-Esprit Interface Option, Model V1000Respironics California, Inc.200406
+4K032551Masimo Lnop-TF-I Resuable Transflectance SensorMasimo Corp.20041—
+4K031740VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc.2003290—
+4K030611Modification to Suzanne Portable Polysomnograph SystemNellcor Puritan Bennett (Melville), Ltd.20030—
+5K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+5K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+5K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—
+5K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+5K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+5K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.20252—
+5K242798AirmodHeroic Faith International, Ltd.20251—
+5K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+5K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+5K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+5K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+5K222597BabySat 3Owlet Babycare, Inc.20230—
+5K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+5K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+5K213911Microstream CO2 NanoPodCovidien, LLC20220—
+5K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+5K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+5K200160740 SafeSATZoe Medical, Inc.20210—
+5K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+5K190561NICU V'02Cosmed Nordic Aps20200—
+5K201699Medline ReNewal Reprocessed Nellcor OxiMax SpO2 SensorSurgical Instrument and Savings Inc (Dba Medline Renewal)20200—
+5K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+5K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.20200—
+5K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+5K200069Disposable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20200—
+5K191989WVSM (Wireless Vital Signs Monitor) RWC + miniCapAthena Gtx20200—
+5K192608Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd20200—
+5K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+5K183521CNAP MonitorCnsystems Medizintechnik GmbH20191—
+5K183282Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd.20192—
+5K191207Guardian Angel Rx GA2001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+5K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI…Nonin Medical, Inc.20190—
+5K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+5K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+5K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC201840—
+5K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+5K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+5K170820Capnograph and OximeterCmi Health, Inc.20181—
+5K172959PeraServer and PeraTrendPerahealth, Inc.20181—
+5K171241Pulse OximeterHunan Accurate Bio-Medical Technology Co., Ltd.20180—
+5K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+5K172482The Nellcor pulse oximetry monitor interface cableCovidien20171—
+5K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring…Capsule Technologie Sas20172—
+5K170182Cardiovit FT-1Schiller AG20170—
+5K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+5K161420Moves SLCThornhill Research, Inc.20170—
+5K163065T3 SoftwareEtiometry, Inc.201715—
+5K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+5K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+5K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+5K160981Patient MonitorEdan Instruments, Inc.201681
+5K160940Masimo Disposable Transflectance Forehead SensorMasimo Corporation20160—
+5K152659V10Mediana Co., Ltd.20162—
+5K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+5K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+5K153275Aingeal Activity SystemIntelesens, Ltd.20160—
+5K152831Spot SkanSkanray Technologies Private Limited20160—
+5K151512Star 60Skanray Technologies Private Limited20160—
+5K151835Vital Signs Patch SystemLifewatch Technologies, Ltd.20160—
+5K150992Vios Monitoring SystemVios Medical, Inc.20157—
+5K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc.201543—
+5K151027zensor systemIntelesens Limited20150—
+5K151305SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model…Nonin Medical, Inc.20151—
+5K142827Visi Mobile Monitoring System, Visi Mobile Chest SensorSotera Wireless, Inc.20150—
+5K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328