510(k) Report

Devices descending from K913695

199 later devices reach Nellcor (R) N-180 Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K970182Dinamap Compact MonitorJohnson & Johnson Medical, Inc.199741—
+1K964978Vital Statistics System (O-Cath Accessory)Quinton, Inc.19970—
+1K952912Spacelabs Medical Integrated Multi-Parameter ModuleSpacelabs Medical, Inc.1997150—
+1K962781Corometrics Model 510 and 511 MonitorGe Medical Systems Information Technologies199701
+1K955113Dinamap Select Multi-Parameter SystemJohnson & Johnson Medical, Inc.199644—
+1K961450Score SoftwareNellcor Puritan Bennett, Inc.199613—
+2K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG2010312
+2K033307Nvision Data Management SoftwareNonin Medical, Inc.20047—
+2K013862Bci 1621 Oximetry Data Management ProgramBci, Inc.20020—
+2K992638Dinamap Pro Series Monitor, Models 100, 200, 300, 400Critikon Company, LLC200040—
+2K982641Advanced Nibp ModuleJohnson & Johnson Medical, Inc.19990—
+2K972502Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc.19981493
+2K971569Dinamap MPS Portable MonitorJohnson & Johnson Medical, Inc.199743—
+3K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG20240—
+3K162014Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2…Bluepoint Medical GmbH & Co. KG20170—
+3K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC…Sentec AG201519
+3K092678Evision Data Management SoftwareNonin Medical, Inc.20094—
+3K080348Oxiscan II Data Management SystemAirsep Corp.20080—
+3K070342Clinical Electronic Thermometer, Models TP11403 Through TP11413American I.V. Products, Inc.20070—
+3K063055VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200613—
+3K052544Pulse Oximeter Adapter CablesAmerican I.V. Products, Inc.20060—
+3K060616Nposes (Nocturnal Pulse Oximetry Study Expert System), Model Nposes-100PHD Medical20060—
+3K050605Spacelabs Medical Multiparameter Module 91496Spacelabs Medical, Inc.200511
+3K050175Spacelabs Medical Multiparameter Module 91496Spacelabs Medical, Inc.20052—
+3K020550Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp.2002751
+3K014255Dinamap Procare Series Monitor; Model 100, 200, 300, 400Ge Medical Systems Information Technologies200222—
+3K020022Dinamap Pro Series Monitor, Models 110, 210, 310, 410Ge Medical Systems Information Technologies200211
+3K993531Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp.20001191
+3K983996Spacelabs Medical Ultraview Digital Telemtry SystemSpacelabs Medical, Inc.199926—
+3K982342Dinamap MPS Select Portable MonitorCritikon Company, LLC19980—
+4K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+4K121480Ariatele Telemetry Transmitter (96281)Spacelabs Healthcare201202
+4K103142Spacelabs Multi-Parameter ModuleSpacelabs Healthcare, Inc.2011014
+4K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+4K100740MD2000B Vital Sign Monitor, Model MD2000BBeijing Choice Electronic Technololgy Co., Ltd.20102—
+4K101127Patient Monitor, Model PM50Contec Medical System Co., Ltd.20100—
+4K090443Planet 55, Model 100Larsen & Toubro Limited20090—
+4K082787Vital Signs Monitor, Model: MD500BBeijing Choice Electronic Technololgy Co., Ltd.20090—
+4K081800T12S Telemetry TransmitterMortara Instrument, Inc.200831
+4K080192Hypervisor VI Central Monitoring System (Including TMS)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2008202
+4K072235PM-50 Pulse Oximeter and VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200772
+4K070791PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd.200747—
+4K062144Escort M8 Vital Signs Patient Monitor, Model 3810Invivo Corporation200611—
+4K041907Trio MonitorDatascope Corp.20040—
+4K032733PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd.200488—
+4K031849Spectrum Patient Monitor, Model 0998-00-0500-XxxxxDatascope Corp.200391
+4K022193Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400NGe Medical Systems Information Technologies200221—
+4K021435Dinamap Pro Series Monitor, Models 110N,210N,310N,410NGe Medical Systems Information Technologies200201
+5K211754Vital Signs MonitorBeijing Choice Electronic Technology Co., Ltd.20210—
+5K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+5K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+5K140852Vectraplex CMSVectracor, Inc.20150—
+5K141020Surveyor S4 Mobile MonitorMortara Instrument, Inc.20142—
+5K142601Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co.201411
+5K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+5K132036Hypervisor Central Monitoring System (Including Telemetry Monitoring System, TMS-6016)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201417—
+5K132037Vital Signs MonitorMindray North America201432
+5K132038Accutorr 7 Vital Signs MonitorMindray North America20142—
+5K130056Patient MonitorLd Technology, LLC20130—
+5K112877Comen Multi-Parameter Patient MonitorGoldway (Us), Inc.20121—
+5K091834Passport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division200902
+5K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO2009101
+5K082887PM-1000F+Patient MonitorAdvanced Instrumentations, Inc.20090—
+5K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+5K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+5K073203Carescape V100Ge Medical Systems Information Technologies200720—
+5K072346PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200719—
+5K062098Spectrum Monitor, Model 0998-00-1000-XxxxxDatascope Corp.20077—
+5K043348Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200587—
+6K233827OxiWearOxiwear, Inc.20240—
+6K221113Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+6K202892Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc.202111
+6K182297Surveyor S2Mortara Instrument, Inc.20190—
+6K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+6K170712Accutorr 7/VS-900 Vital Signs MonitorShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201711
+6K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+6K161056Telemetry TransmitterEdan Instruments, Inc.201702
+6K160685Surveyor S4 Mobile MonitorMortara Instrument, Inc.201601
+6K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+6K150632Hypervisor IX Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2015142
+6K132229Omni Patent MonitorsInfinium Medical20142—
+6K130740Nightingale Monitoring SystemZoe Medical, Inc.20133—
+6K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc.201321
+6K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+6K110922Patient MonitorEdan Instruments, Inc.201111
+6K101692Patient MonitorContec Medical System Co., Ltd.201101
+6K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies201011—
+6K102004Endeavour Monitoring SystemMindray DS USA, Inc.201033
+6K093802Ultraview DM3 MonitorZoe Medical, Inc.201002
+6K100046M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd.201016—
+6K092970General Patient Monitors, Models: G3C/ G3D/ G3F/ G3G/ G3HGeneral Meditech, Inc.20100—
+6K092727H100B Pulse OximeterEdan Instruments, Inc.20090—
+6K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc.200912
+6K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+6K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+6K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+6K060281VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200616—
+6K053193PM-8000 Express Patient Monitor, Model PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd.200648—
+6K053234PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006711
+7K233038Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc.202401