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
+1K090892GE Datex-Ohmeda S/5 Adu CarestationGE Healthcare Finland Oy200901
+1K050676GE Detax-Ohmeda Anesthesia Delivery Unit (Adu)Datex-Ohmeda, Inc.200513
+1K042154GE Datex-Ohmeda Aisys CarestationDatex-Ohmeda, Inc.2004363
+1K040847Modification to Vamos Anesthetic Gas MonitorDraeger Medical, Inc.2004270—
+1K032803Datex-Ohmeda S/5 Avance Anesthesia SystemDatex-Ohmeda200439—
+1K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc.2003134Class I
+2K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class I
+2K061609GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.2006341
+2K053204Intellivue Gas Modules, Models G5 M1019A and G1 M1013ADraeger Medical AG & Co. Kgaa2006222—
+2K051222AV-S Anaesthesia VentilatorPenlon Limited20050—
+2K051628Infinity Monitors with Scio ModificationsDraeger Medical Systems, Inc.2005230—
+2K050626GE Datex-Ohmeda Aespire 7900 Anesthesia SystemDatex-Ohmeda, Inc.200541
+2K042607Primus USDraeger Medical, Inc.2004102
+2K041775GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.2004107—
+2K042419Fabius GS/Fabius Tiro Anesthesia SystemDraeger Medical, Inc.20041Class I
+2K042086Fabius GS Anesthesia System; Fabius Tiro Anesthesia SystemDraeger Medical, Inc.20042—
+2K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa2004251—
+2K040743Modification to Datex-Ohmeda S/5 Avance Anesthesia SystemDatex-Ohmeda, Inc.200438—
+3K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+3K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+3K133886Perseus A500Draeger Medical GmbH20142Class I
+3K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+3K092864Aespire 7900, Aespire ViewDatex-Ohmeda Inc., A Division of Instrumentarium C20103—
+3K072884Fabius MriDraeger Medical AG & Co. KG20080Class I
+3K071142GE Datex-Ohmeda Avance Anesthesia SystemDatex-Ohmeda200733—
+3K070566Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XLDraeger Medical Systems, Inc.2007266
+3K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH20062212
+3K051895GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.200549—
+3K051767LTV 1000 VentilatorPulmonetic Systems, Inc.200557—
+3K050860GE Datex-Ohmeda Centiva/5 VentilatorDatex-Ohmeda, Inc.20050—
+3K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH2005249—
+3K050597GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.20050—
+4K253807Valence InVent Xtend™ (CVG-4101-VXA)Convergence Medical Sciences, Ltd.20260—
+4K230931AtlanDrägerwerk AG Co. Kgaa20231Class I
+4K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+4K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+4K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH20177—
+4K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+4K152407Infinity Delta, Infinity Delta XL, Infinity KappaDraeger Medical Sytems, Inc.201504
+4K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328
+4K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+4K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+4K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+4K122445Aespire 7900, Aespire ViewDatex-Ohmeda20122Class I
+4K120087ExspironRespiratory Motion, Inc.20128—
+4K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+4K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+4K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH201281—
+4K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2012781
+4K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011841
+4K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2011902
+4K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boblingen GmbH2010103—
+4K093268Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20101052
+4K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010123—
+4K093788Infinity Acute Care System (Iacs) Monitoring SolutionDraeger Medical Systems, Inc.2010244
+4K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+4K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009124—
+4K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group200926Class I
+4K082583Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009945
+4K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20091252
+4K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc.200892
+4K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20081273
+4K081844GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.2008304
+4K080175Navigator Anesthesia Delivery System, Model 0998-00-3024-01Datascope Corp., Patient Monitoring Division2008112
+4K070899Puritan Bennett Legendair XL2Nellcor Puritan Bennett20078Class I
+4K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007151—
+4K062710GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.2006472
+4K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90Philips Medizin Systeme Boeblingen GmbH2006154—
+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—
+4K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006155—
+4K060862GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.2006481
+4K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc.2006211—
+4K060647LTV 1200 VentilatorPulmonetic Systems, Inc.200629—
+4K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006222—
+4K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Philips Medizin Systeme Boeblingen GmbH2006233—
+4K052961The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors…Philips Medical Systems2005180—
+4K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH2005234—
+4K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2005247—
+5K252746Atlan (A100); Atlan (A100 XL); Atlan (A350); Atlan (A350 XL)Drägerwerk AG Co. Kgaa20260—
+5K201082LTV2 Series VentilatorsVyaire Medical, Inc.20210—
+5K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+5K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+5K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC20202—
+5K183226Care Orchestrator EssenceRespironics, Inc.20190—
+5K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+5K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC201840—
+5K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+5K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+5K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+5K153156eCareManager 4.0.1Visicu, Inc.20163—
+5K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+5K152552Patient MonitorEdan Instruments, Inc.201621
+5K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+5K150512STAR 90Skanray Technologies Pvt, Ltd.20151—
+5K141943Breathe Technologies LIFE2000 Ventilation SystemBreathe Technologies20151—
+5K143530Aespire ViewDatex-Ohmeda, Inc.201511
+5K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+5K133868Astral VentilatorResmed, Ltd.2014102
+5K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361