510(k) Report

Devices descending from K060576

140 later devices reach Nellcor Oximax N-600X Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161909IQvitals ZoneMidmark Corporation201614
+1K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+1K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+1K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+1K103166Cheetah ReliantCheetah Medical, Inc.20111—
+1K090360Philips M3001A Multi Measurement ServerPhilips Medizin Systeme Boblingen GmbH200984—
+1K083325N-600X with SPD, Oximax N-600XCovidien200953—
+2K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+2K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+2K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+2K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+2K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328
+2K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+2K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+2K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+2K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+2K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+2K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+2K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+2K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien201245—
+2K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+2K120773Nellcor Bedside SPO2 Patient Monitoring SystemCovidien, LLC201261
+2K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien201249—
+2K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc.20110—
+2K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+3K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+3K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—
+3K242798AirmodHeroic Faith International, Ltd.20251—
+3K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+3K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+3K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+3K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+3K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+3K142865Nellcor Bedside SpO2 Patient Monitoring SystemCovidien, LLC201531
+3K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien201529—
+3K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+3K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Covidien201440—
+3K131085Central Venous Pressure System - Mespere Venus 1000Mespere Lifesciences, Inc.20131—
+3K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+4K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+4K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+4K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+4K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+4K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+4K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+4K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+4K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+4K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+4K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+4K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+4K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+4K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+4K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+4K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+4K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+4K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+4K172482The Nellcor pulse oximetry monitor interface cableCovidien20171—
+4K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+4K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+4K152659V10Mediana Co., Ltd.20162—
+4K152043Diagnostic Station DS20Schiller AG20161—
+4K151776Central Venous Pressure SystemMespere Lifesciences, Inc.20150—
+4K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+4K140430740 SelectCas Medical Systems, Inc.20141—
+4K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+5K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+5K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+5K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+5K214115MightySat -OTCMasimo Corporation20241—
+5K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+5K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+5K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+5K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+5K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+5K220111RespiraSensePmd Solutions20221—
+5K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+5K213911Microstream CO2 NanoPodCovidien, LLC20220—
+5K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+5K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+5K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+5K211632Pulse 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—
+5K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+5K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+5K201179GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableCovidien, LLC20200—
+5K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+5K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+5K181352Loop SystemSpry Health, Inc.201910—
+5K170497V10Mediana Co., Ltd.201711
+5K170182Cardiovit FT-1Schiller AG20170—
+5K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+5K150620740 SelectCas Medical Systems, Inc.201501
+5K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+6K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+6K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+6K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+6K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+6K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+6K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+6K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+6K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—