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
+5K150620740 SelectCas Medical Systems, Inc.201501
+5K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+5K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd.20146—
+5K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+5K133879Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.201444—
+5K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+5K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+5K131379EarlysenseEarlysense, Ltd.20137—
+5K133586Visi Mobile Monitioring SystemSotera Wireless, Inc.201318—
+5K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+5K132808Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc.20136—
+5K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+5K130709Visi Mobile Monitoring SystemSotera Wireless, Inc.201319—
+5K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+5K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+5K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+5K130957WVSM (Wirless Vital Signs Monitor)Athena Gtx20131—
+5K123700Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.20130—
+5K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien201245—
+5K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+5K113045BioharnessZephyr Technology Corporation20122—
+5K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+5K120773Nellcor Bedside SPO2 Patient Monitoring SystemCovidien, LLC201261
+5K113215Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc.201242—
+5K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH201281—
+5K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2012781
+5K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+5K113653Patient MonitorEdan Instruments, Inc.201212
+5K113165Mini-MedicAthena Gtx201213—
+5K112820Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc.201247—
+5K102047Lci Option for InnocorInnovision A/S201101
+5K102063Health-E-Connect SystemAlr Technologies20111—
+5K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011841
+5K110922Patient MonitorEdan Instruments, Inc.201111
+5K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc.20110—
+5K103578Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC20114—
+5K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2011902
+5K103142Spacelabs Multi-Parameter ModuleSpacelabs Healthcare, Inc.2011014
+5K102968Infinity Cnap SmartpodDraeger Medical Systems, Inc.20112—
+5K110168Zoll E Series with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters201115—
+5K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+5K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boblingen GmbH2010103—
+5K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies201011—
+5K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+5K093895Ally Platform SystemContinuity Health Solutions20100—
+5K093268Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20101052
+5K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010123—
+5K092031Vapor-Clear, Model 100Axon Medical, Inc.201001
+5K093923Cerox Model 3210Or-Nim Medical, Ltd.20100—
+5K091265Zoll E Series with CprreadychargeZoll Medical Corporation, World Wide Headquarters20090—
+5K092598Zoll E Series with Spco/Spmet OptionZoll Medical Corporation, World Wide Headquarters20092—
+5K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009124—
+5K090989Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp200927—
+5K092217Mercury VCO2Respironics Novametrix, Inc.200904
+5K083750Capnostat / Capnoflex CO2 SystemGe Medical Systems Information Technologies20090—
+5K083697Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…Fukuda Denshi USA, Inc.20092—
+5K081081Zoll E Series with Bluetooth Dial UP NetworkingZoll Medical Corporation, World Wide Headquarters20090—
+5K083079Quanta Pulse Oximeter, Model: Pulse Link 1000 or QH100Quanta Computer, Inc.20090—
+5K082583Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009945
+5K083879Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath…Innovision A/S20092—
+5K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc.20091709
+5K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20091252
+5K080903Zoll E Series with Intibation Assist OptionZOLL Medical Corporation20083—
+5K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+5K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20081273
+5K080232Zoll E Series 12SL, Analysis OptionZoll Medical Corporation, World Wide Headquarters20080—
+5K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086—
+5K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+5K071911Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S20073—
+5K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007151—
+5K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007175—
+5K063419Modification to VSM- Vital Signs Monitor, (VSM 300 )Welch Allyn Protocol, Inc.2006751
+5K062271M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150…Philips Medical Systems200693
+5K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90Philips Medizin Systeme Boeblingen GmbH2006154—
+5K062095Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.20063—
+5K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc.2006188—
+5K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2006176—
+5K060559Zoll R Series DefibrillatorZOLL Medical Corporation2006211
+5K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006155—
+5K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc.2006211—
+5K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH20062212
+5K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006222—
+5K053027VSM Vital Signs Monitor, Model 53000 (VSM 300)Welch Allyn, Inc.200531
+6K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+6K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+6K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+6K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+6K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+6K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+6K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.20251—
+6K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+6K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+6K233827OxiWearOxiwear, Inc.20240—
+6K214115MightySat -OTCMasimo Corporation20241—
+6K223721Masimo StorkMasimo Corporation20230—
+6K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+6K231035FusedCO AlgorithmEdwards Lifesciences, LLC20230—
+6K230386SpassageQSpass, Inc.20231—
+6K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+6K222897Enlight 2100Timpel S.A.20232—