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
+6K094012CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc.201093—
+6K093907Welch Allyn Non Invasive Blood Pressure (Nibp) DeviceWelch Allyn, Inc.201074—
+6K092727H100B Pulse OximeterEdan Instruments, Inc.20090—
+6K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation2009155—
+6K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+6K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+6K091395MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200984—
+6K081828Zoll R Series BLS DefibrillatorZOLL Medical Corporation20088—
+6K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Philips Medizin Systeme Boeblingen GmbH2008143—
+6K081574Zoll R SeriesZOLL Medical Corporation20088—
+6K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+6K081983M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems200883
+6K082045Modification to Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.200801
+6K072070Philips MP2 and X2 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007119—
+7K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+7K253274BedDot (G1)Intelligent Dots, LLC20260—
+7K253650Anura Mobile Core SDK (M1)Nuralogix Corporation20260—
+7K253436c-med0 alphaCosinuss GmbH20260—
+7K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+7K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+7K250464Enlight 2100 (TPL-E2103-0)Timpel S.A.20250—
+7K243765LuMon (TM) SystemSentec AG20250—
+7K244007ArteVuCardio Ring Technologies, Inc. Taiwan Branch20250—
+7K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+7K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+7K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+7K241397HinscopeHinlab Sas20240—
+7K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+7K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+7K240558NavoycdsAlgodx AB20240—
+7K232445CSF-4 (CSF-4)Cardiacsense20240—
+7K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+7K231625VitalDetectWellvii, Inc.20240—
+7K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+7K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+7K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+7K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+7K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+7K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+7K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+7K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+7K223073AlioAlio, Inc.20230—
+7K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+7K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+7K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+7K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+7K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+7K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+7K220351Polso WatchChronisense Medical, Ltd.20220—
+7K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+7K222550Current Health SystemCurrent Health, Ltd.20221—
+7K220111RespiraSensePmd Solutions20221—
+7K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+7K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+7K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+7K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+7K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+7K211305ANNE OneSibel, Inc.20216—
+7K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+7K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical20210—
+7K201887VS Newborn Heart Rate MonitorSurepulse Medical Limited202105
+7K202868LifeSignals Multi-Parameter Remote Monitoring PlatformLifesignals, Inc.20213—
+7K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+7K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+7K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+7K202336Patient MonitorEdan Instruments, Inc.202131
+7K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+7K202306T3 Platform softwareEtiometry, Inc.202013—
+7K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+7K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+7K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+7K193415physIQ Heart Rhythm and Respiration ModulePhysiq, Inc.20200—
+7K191620Vitls PlatformVitls, Inc.20202—
+7K193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2…Vitalconnect, Inc.202001
+7K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC20202—
+7K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+7K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+7K191331Life Sensor Cardiac MonitorBraveheart Wireless, Inc.20190—
+7K182429Masimo O3 Regional Oximeter SystemMasimo Corporation20193—
+7K183078VitalConnect Platform, VitalPatch BiosensorVitalconnect, Inc.20199—
+7K180902MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable AssemblyMedipines Corporation20190—
+7K180482ZOLL Propaq MZOLL Medical Corporation20182—
+7K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+7K180003FORE-SIGHT ELITE Module Tissue OximeterCas Medical Systems, Inc.2018291
+7K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…Hill-Rom, Inc.20182—
+7K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+7K172226MX40 Release B.07Philips Medical Systems201713—
+7K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+7K171322eCareManager 4.1Visicu, Inc.20172—
+7K162603Masimo O3 Regional Oximeter SystemMasimo Corporation20170—
+7K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+7K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+7K153335AlertWatch: ORAlertwatch, LLC20161—
+7K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+7K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+7K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+7K152341ViSi Mobile Monitoring SystemSotera Wireless, Inc.20154—
+7K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+7K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+7K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501