510(k) Report

Devices descending from K993516

336 later devices reach HP M2600A Viridia Telemetry System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+4K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+4K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+4K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+4K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+4K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+4K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+4K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC20202—
+4K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+4K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+4K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+4K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+4K180017MX40 Release C.01Philips Medical Systems20181—
+4K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+4K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+4K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+4K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+4K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+4K153156eCareManager 4.0.1Visicu, Inc.20163—
+4K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+4K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+4K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+4K153335AlertWatch: ORAlertwatch, LLC20161—
+4K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+4K142106Decisio Health Patient DashboardDecisio Health, Inc.20155—
+4K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+4K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+4K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc.20141—
+4K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+4K130170Exspiron 1XIRespiratory Motion, Inc.20134—
+4K120173Patient MonitorEdan Instruments, Inc.201210—
+4K113653Patient MonitorEdan Instruments, Inc.201212
+4K113623Patient MonitorEdan Instruments, Inc.2012152
+4K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201092—
+4K092028Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH20103—
+4K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+4K071800Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN200774
+4K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007175—
+4K062137Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200682
+5K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc.20260—
+5K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+5K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+5K250955XC11 ICE System, USAYorlabs, Inc.20250—
+5K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+5K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+5K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+5K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20241—
+5K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+5K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+5K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+5K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+5K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+5K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+5K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+5K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+5K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+5K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+5K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+5K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+5K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+5K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+5K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+5K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+5K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+5K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+5K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+5K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+5K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+5K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+5K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+5K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+5K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+5K173715AlertWatch:OBAlertwatch, Inc.20180—
+5K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+5K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+5K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+5K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+5K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+5K171322eCareManager 4.1Visicu, Inc.20172—
+5K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems20172—
+5K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+5K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+5K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+5K160981Patient MonitorEdan Instruments, Inc.201681
+5K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+5K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+5K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+5K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+5K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+5K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH20112—
+5K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH20104—
+5K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+6K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+6K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+6K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+6K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+6K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+6K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+6K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+6K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—