510(k) Report

Devices descending from K991823

785 later devices reach N-395 Pulse Oximeter, Model N-395 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K090989Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp200927—
+4K092217Mercury VCO2Respironics Novametrix, Inc.200904
+4K083750Capnostat / Capnoflex CO2 SystemGe Medical Systems Information Technologies20090—
+4K083697Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…Fukuda Denshi USA, Inc.20092—
+4K081081Zoll E Series with Bluetooth Dial UP NetworkingZoll Medical Corporation, World Wide Headquarters20090—
+4K083079Quanta Pulse Oximeter, Model: Pulse Link 1000 or QH100Quanta Computer, Inc.20090—
+4K082583Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009945
+4K083879Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath…Innovision A/S20092—
+4K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc.20091709
+4K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20091252
+4K080903Zoll E Series with Intibation Assist OptionZOLL Medical Corporation20083—
+4K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+4K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20081273
+4K080232Zoll E Series 12SL, Analysis OptionZoll Medical Corporation, World Wide Headquarters20080—
+4K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086—
+4K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+4K071911Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S20073—
+4K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007151—
+4K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007175—
+4K063419Modification to VSM- Vital Signs Monitor, (VSM 300 )Welch Allyn Protocol, Inc.2006751
+4K062271M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150…Philips Medical Systems200693
+4K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90Philips Medizin Systeme Boeblingen GmbH2006154—
+4K062095Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.20063—
+4K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc.2006188—
+4K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2006176—
+4K060559Zoll R Series DefibrillatorZOLL Medical Corporation2006211
+4K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006155—
+4K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc.2006211—
+4K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH20062212
+4K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006222—
+4K053027VSM Vital Signs Monitor, Model 53000 (VSM 300)Welch Allyn, Inc.200531
+5K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+5K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics Co., Ltd.20260—
+5K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+5K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…Unimed Medical Supplies, Inc.20250—
+5K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…Unimed Medical Supplies, Inc.20250—
+5K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…Unimed Medical Supplies, Inc.20250—
+5K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+5K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+5K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+5K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+5K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+5K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.20251—
+5K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc.20251—
+5K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+5K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+5K214115MightySat -OTCMasimo Corporation20241—
+5K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+5K231035FusedCO AlgorithmEdwards Lifesciences, LLC20230—
+5K230386SpassageQSpass, Inc.20231—
+5K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+5K222897Enlight 2100Timpel S.A.20232—
+5K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+5K212473Welch Allyn Connex Central StationWelch Allyn, Inc.20220—
+5K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+5K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+5K211365Alio Medical Remote Monitoring SystemGraftworx, Inc. Dba Alio20223—
+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—
+5K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+5K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+5K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+5K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+5K202851Spo2 SensorJkh USA, LLC20201—
+5K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+5K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+5K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.20201—
+5K201179GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableCovidien, LLC20200—
+5K200690LifeSignals ECG Remote Monitoring Patch PlatformLifesignals, Inc.20201—
+5K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+5K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+5K192488CO2 Sidestream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20200—
+5K192514Patient MonitorEdan Instruments, Inc.202061
+5K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+5K192584BEACON Caresystem Model 00002144Mermaid Care A/S20190—
+5K190273T3 Platform softwareEtiometry, Inc.201914—
+5K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd.20191—
+5K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+5K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+5K183370PeraMobile and PeraWatchPerahealth, Inc.20190—
+5K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+5K190792BB-613WPBiobeat Technologies, Ltd.201912—
+5K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+5K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+5K183322physIQ Heart Rhythm and Respiratory ModulePhysiq, Inc.20191—
+5K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+5K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+5K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorNihon Kohden Corporation20190—
+5K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+5K181352Loop SystemSpry Health, Inc.201910—
+5K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+5K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+5K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+5K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC20181—
+5K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.20181—
+5K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+5K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+5K173368Reusable & Disposable SpO2 SensorsShenzhen Coreray Technology, Ltd.20180—
+5K180734SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie20180—
+5K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824