510(k) Report

Devices descending from K974176

151 later devices reach Babylog 8000 Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103211Avea VentilatorCare Fusion20115Class I
+1K100011Fisher & Paykel Healthcare Bubble Cpap SystemFisher & Paykel Healthcare, Ltd.20103—
+1K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C201021—
+1K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa201010Class I
+1K083050Evite XLDraeger Medical AG & Co. KG20082—
+1K062710GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc.2006472
+1K992788Bear Cub 750 PSVBear Medical Systems, Inc.1999134—
+2K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+2K221436F&P 950 Accessory Breathing Circuit KitsFisher & Paykel Healthcare, Ltd.20230—
+2K220107Mindray SV600 Ventilator, Mindray SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+2K222207Babylog VN800, Babylog VN600Draegerwerk AG & CO Kgaa20230—
+2K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+2K143700CPAP CannulaideSalter Labs20150—
+2K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+2K131502Seattle - PapSeattle Childrens Hospital20130Class I
+2K121225Hamilton-C2Hamilton Medical AG20128Class I
+2K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+2K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+2K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+2K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.200837—
+2K081521Modification to Hamilton-G5Hamilton Medical AG200816Class I
+2K080181Modification to Galileo GoldHamilton Medical AG200821—
+2K013642AVEABird Products Corp.2002133Class I
+3K233486731 Series VentilatorZOLL Medical Corporation20240—
+3K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class I
+3K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+3K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+3K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+3K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+3K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+3K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc.201323
+3K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+3K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+3K123637Hamilton-C3Hamilton Medical AG20124—
+3K110083V200 Ventilator with Aprv Mode, Esprit Ventilator with Aprv ModeRespironics California, Inc.20120—
+3K103803Hamilton-G5Hamilton Medical AG201114Class I
+3K102775Hamilton-C2Hamilton Medical AG201114—
+3K090468Hamilton-C2Hamilton Medical AG20090—
+3K081837Avea VentilatorCardinal Health 207, Inc.200813—
+3K062793Servo-I Ventilator System, Model 64 87 800 E407E; Nava OptionMaquet Critical Care AB20070—
+3K032451Bird Tbird Vela VentilatorBird Products Corp.20041141
+3K022674Bird Avea VentilatorBird Products Corp.2002585
+4K251133AVEA disposable expiratory filter/water trap (11790)Telesair, Inc.20250—
+4K210384Carescape R860Datex-Ohmeda, Inc.20210—
+4K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+4K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+4K170872Aisys CS2Datex-Ohmeda, Inc.201704
+4K161450Hamilton-C3Hamilton Medical AG201732
+4K153046Hamilton-MR1Hamilton Medical AG20160Class I
+4K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+4K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+4K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+4K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+4K131774Hamilton-G5Hamilton Medical AG201310Class I
+4K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+4K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+4K112006Hamilton-TC1Hamilton Medical AG201213—
+4K111683Flight 60 VentilatorFlight Medical Innovations, Ltd.20114—
+4K092847840 Ventilator System with Expanded Neomode OptionCovidien, Formerly Nellcor Puritan Bennett, Inc.201011—
+4K071526Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc.200871
+4K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB200828—
+4K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.200712Class I
+4K060647LTV 1200 VentilatorPulmonetic Systems, Inc.200629—
+4K053270IVENT 201Versamed Medical Systems, Inc.200687—
+4K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc.2005112—
+4K041524GE Datex-Ohmeda Heliox Delivery SystemDatex-Ohmeda, Inc.200430—
+5K201082LTV2 Series VentilatorsVyaire Medical, Inc.20210—
+5K201306Hamilton-C3Hamilton Medical AG20210Class I
+5K201658Hamilton-C6Hamilton Medical AG20201Class I
+5K180295Hamilton-G5Hamiton Medical AG20192—
+5K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+5K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+5K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+5K151252Puritan Bennett 840 Series Ventilator SystemCovidien LP20167—
+5K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+5K141943Breathe Technologies LIFE2000 Ventilation SystemBreathe Technologies20151—
+5K123149Servo-I Ventilator SystemMaquet Critical Care AB201492
+5K133868Astral VentilatorResmed, Ltd.2014102
+5K120574Hamilton-C1Hamilton Medical AG20123—
+5K120670Hamilton-T1Hamilton Medical AG201211Class I
+5K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+5K101643Model LTV 1100 VentilatorCare Fusion20111—
+5K093094Vela VentilatorCardinal Health 207, Inc.20102—
+5K093261MOVESThornhill Research, Inc.20107Class I
+5K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+5K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc.200961
+5K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+5K081845IVENT101Versamed Medical Systems, Inc.20090—
+5K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc.200892
+5K072926Helontix VentLinde Gas Therapeutics20080—
+5K061627Modification to I Vent 201Versamed Medical Systems, Inc.200686—
+5K060705Carina HomeDraeger Medical B.V.2006221
+6K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+6K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+6K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I
+6K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+6K193228Hamilton-G5Hamilton Medical AG20201—
+6K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+6K181166Trilogy EvoRespironics, Inc.20195Class I
+6K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902