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
+3K041815LNCS Oximetry SensorsMasimo Corp.200486—
+3K041204NC SP02 Adapter CableMasimo Corp.20040—
+3K040589Modification to Avant 9600 Pulse OximeterNonin Medical, Inc.200427—
+3K033048Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL…Cas Medical Systems, Inc.20042721
+3K032755Model 509M Pulse Oximeter, Model 509MRespironics Novametrix, Inc.200401
+3K033876Dolphin 2000 Oximetry Sensors, Models 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342…Dolphin Medical, Inc.20040—
+3K033378Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc.20041083
+3K032363Zoll M Series Nibp OptionZoll Medical Corp2003114—
+3K030886Nico with Mars, Model 7300Respironics Novametrix, Inc.20032468
+3K031742Bci 6004 Nibp Monitor with Nellcor Pulse OximeterBci, Inc.200301
+3K030930Oximax Softcare Sensors, Models SC-a, SC-PR, SC-Neo, SC-NNellcor Puritan Bennett, Inc.20034—
+3K022163Welch Allyn Spot Vital Sign Monitor with MP506Welch Allyn, Inc.20020—
+3K022677Medley SPO2 Module, Model 8210 & SPO2 Sensors & CableAlaris Medical Systems, Inc.200202
+3K022193Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400NGe Medical Systems Information Technologies200221—
+3K021089Oximax Max-Fast Adhesive Forehead SensorNellcor Puritan Bennett, Inc.200213—
+3K021435Dinamap Pro Series Monitor, Models 110N,210N,310N,410NGe Medical Systems Information Technologies200201
+3K021090Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc.2002426—
+4K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics Co., Ltd.20260—
+4K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+4K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…Unimed Medical Supplies, Inc.20250—
+4K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…Unimed Medical Supplies, Inc.20250—
+4K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…Unimed Medical Supplies, Inc.20250—
+4K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc.20251—
+4K211140Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse…Stryker Sustainability Solutions20222—
+4K202851Spo2 SensorJkh USA, LLC20201—
+4K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.20201—
+4K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd.20191—
+4K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+4K192322T-Stat 2.0 Microvascular Tissue OximeterSpectros Corporation20190—
+4K191018Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive SensorsSurgical Instrument Service and Savings, Inc.20190—
+4K181738Medline ReNewal Reprocessed OxiMax Pulse Oximetry SensorsSurgical Instrument Service and Savings Inc (Dba Medline20191—
+4K182822Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20196—
+4K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+4K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.20181—
+4K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+4K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.20180—
+4K173045OximeterShenzhen Greatmade Tech Limited20180—
+4K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+4K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+4K161909IQvitals ZoneMidmark Corporation201614
+4K160582WiCapAthena Gtx20160—
+4K152043Diagnostic Station DS20Schiller AG20161—
+4K152258T3 SoftwareEtiometry, Inc.201616—
+4K151940Thora-3Di, Model T-01Pneumacare Limited20163—
+4K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+4K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+4K142512Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq)20153—
+4K142865Nellcor Bedside SpO2 Patient Monitoring SystemCovidien, LLC201531
+4K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+4K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+4K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien201529—
+4K132407Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd.20141—
+4K141542Nellcor Portable SPO2 Patient Monitoring System ( Npspms )Covidien, LLC20140—
+4K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+4K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+4K141167Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and…Vitalconnect, Inc.201470—
+4K140430740 SelectCas Medical Systems, Inc.20141—
+4K140049Moves SLCThornhill Research, Inc.20141—
+4K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd.20143—
+4K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+4K130740Nightingale Monitoring SystemZoe Medical, Inc.20133—
+4K124038Bedside Paediatric Early Warning System (Bedsidepews)Bedside Clinical Systems, Inc.20132—
+4K130411740 SelectCas Medical Systems, Inc.20136—
+4K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc.201321
+4K123309Giraffe and Panda WarmersOhmeda Medical20130Class I
+4K112877Comen Multi-Parameter Patient MonitorGoldway (Us), Inc.20121—
+4K122401Tango M2 Blood Pressure MonitorSuntech Medical, Inc.20120—
+4K120052CvinsightIntelomed, Inc.20120—
+4K122036Visi Mobile Monitoring SystemSotera Wireless, Inc.2012202
+4K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201265—
+4K121912E1 Ear SensorsMasimo Corporation20124—
+4K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+4K120465Earlysense (Everon) SystemEarlysense, Ltd.20129—
+4K120173Patient MonitorEdan Instruments, Inc.201210—
+4K112761Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201201
+4K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien201249—
+4K113596Masimo Set Reusable Oximetry SensorsMasimo Corporation20120—
+4K113623Patient MonitorEdan Instruments, Inc.2012152
+4K112190Patient MonitorMediana Co., Ltd.20110—
+4K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsMasimo Corporation201138—
+4K111888Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation201159—
+4K110723M-LNCS Oximetry Sensors, Reprocessed M-LNCS Oximetry SensorsMasimo Corporation20110—
+4K103631Sleepminder Breathing Frequency IndicatorBiancamed Limited20111—
+4K110953Visensia, Visensia with AlertObs Medical201117—
+4K110015Vitalsens, Aingeal, V-PodIntelesens Limited20114—
+4K103166Cheetah ReliantCheetah Medical, Inc.20111—
+4K094030Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000…Cas Medical Systems, Inc.201053—
+4K102715Regional OximeterNonin Medical, Inc.201053—
+4K100040BioharnessZephyr Technology Corporation20103—
+4K102468Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters20109—
+4K101674WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx201017—
+4K100773Kai Spot Model KMS 200Kai Medical, Inc.20100—
+4K094046LNCS Oximetry Sensors, Reprocessed LNCS Oximetry SensorsMasimo Corporation20100—
+4K093802Ultraview DM3 MonitorZoe Medical, Inc.201002
+4K093016Vital Signs MonitorShenzhen Creative Industry Co., Ltd.201016—
+4K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc.200912
+4K091787Model 6000 Two Parameter Bedside MonitorIvy Biomedical Systems, Inc.20090—
+4K091459Philips NM3 Monitor, Model 7900Respironics Novametrix, LLC200954
+4K083821Vital Signs MonitorEdan Instruments, Inc.200939—
+4K090360Philips M3001A Multi Measurement ServerPhilips Medizin Systeme Boblingen GmbH200984—