510(k) Report

Devices descending from K973985

400 later devices reach AS/3 Anaesthesia Delivery Unit (as/3 Adu) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America201410—
+5K130401Alertwatch: orAlertwatch, LLC20148—
+5K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+5K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+5K130170Exspiron 1XIRespiratory Motion, Inc.20134—
+5K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+5K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+5K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+5K112754IVENT101Versamed Medical Systems, Ltd.20129—
+5K120173Patient MonitorEdan Instruments, Inc.201210—
+5K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+5K113653Patient MonitorEdan Instruments, Inc.201212
+5K113623Patient MonitorEdan Instruments, Inc.2012152
+5K120075AM-6000 Anesthesia MachineAdvanced Instrumentations, Inc.20120—
+5K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+5K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+5K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+5K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+5K111083Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201111
+5K110809Wireless Monitoring SystemCarefusion 303, Inc.20112—
+5K102471AS3700 Anesthsia Delivery SystemMindray DS USA, Inc.20119Class I
+5K101643Model LTV 1100 VentilatorCare Fusion20111—
+5K103646Intellivue MX40 Patient MonitorPhillips Medical Systems2011161
+5K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+5K100753Flight 60 Ventilator, Model F-60Flight Medical, Ltd.20105—
+5K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201092—
+5K093094Vela VentilatorCardinal Health 207, Inc.20102—
+5K093416Trilogy 200 VentilatorRespironics, Inc.201019Class I
+5K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc.200961
+5K082982Breathe Technologies Ventilator and AccessoriesBreathe Technologies, Inc.20095—
+5K091395MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200984—
+5K081845IVENT101Versamed Medical Systems, Inc.20090—
+5K090233GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.2009192
+5K082966PB 540 VentilatorCovidien, Formerly Nellcor Puritan Bennett, Inc.20080—
+5K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Philips Medizin Systeme Boeblingen GmbH2008143—
+5K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.200837—
+5K081521Modification to Hamilton-G5Hamilton Medical AG200816Class I
+5K080181Modification to Galileo GoldHamilton Medical AG200821—
+5K072070Philips MP2 and X2 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007119—
+5K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.200712Class I
+5K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007175—
+5K062271M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150…Philips Medical Systems200693
+5K052795Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200591
+6K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+6K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+6K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+6K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+6K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20241—
+6K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+6K231035FusedCO AlgorithmEdwards Lifesciences, LLC20230—
+6K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+6K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+6K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+6K220111RespiraSensePmd Solutions20221—
+6K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+6K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+6K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+6K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+6K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+6K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+6K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+6K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+6K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+6K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+6K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+6K181166Trilogy EvoRespironics, Inc.20195Class I
+6K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+6K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+6K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+6K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+6K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+6K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+6K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+6K172226MX40 Release B.07Philips Medical Systems201713—
+6K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+6K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+6K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies20170Class I
+6K171322eCareManager 4.1Visicu, Inc.20172—
+6K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+6K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+6K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+6K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+6K160981Patient MonitorEdan Instruments, Inc.201681
+6K160481Vivo 60Breas Medical AB201672
+6K152068Astral 100/150Resmed, Ltd.20161Class I
+6K151120Simple T Pediatric Nasal MaskRespironics, Inc.20160—
+6K153335AlertWatch: ORAlertwatch, LLC20161—
+6K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+6K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+6K142106Decisio Health Patient DashboardDecisio Health, Inc.20155—
+6K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+6K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+6K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+6K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+6K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc.20141—
+6K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+6K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+6K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+6K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+6K122715Stellar 150Resmed Germany, Inc.20130Class I