510(k) Report

Devices descending from K063404

61 later devices reach Servo-I Ventilator System, Models 64, 87 and 800 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C201021—
+1K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.200837—
+1K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB200828—
+1K073694Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc.20086—
+2K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+2K123149Servo-I Ventilator SystemMaquet Critical Care AB201492
+2K131774Hamilton-G5Hamilton Medical AG201310Class I
+2K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+2K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+2K103803Hamilton-G5Hamilton Medical AG201114Class I
+2K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+2K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+2K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+2K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+2K083688Pulmonetic Systems LTV 1200 MR Conditional VentilatorPulmonetic Systems, Inc.200921
+3K240807VM-2000Ventis Medical, Inc.20240—
+3K202970Ventway SparrowInovytech Medical Solutions, Ltd.20210—
+3K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+3K180295Hamilton-G5Hamiton Medical AG20192—
+3K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class I
+3K161450Hamilton-C3Hamilton Medical AG201732
+3K153688Edi Catheter ENFitMaquet Critical Care AB201711
+3K153046Hamilton-MR1Hamilton Medical AG20160Class I
+3K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB20154—
+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
+3K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+3K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+3K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+3K121225Hamilton-C2Hamilton Medical AG20128Class I
+3K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+3K103211Avea VentilatorCare Fusion20115Class I
+4K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB20260—
+4K210384Carescape R860Datex-Ohmeda, Inc.20210—
+4K201306Hamilton-C3Hamilton Medical AG20210Class I
+4K201658Hamilton-C6Hamilton Medical AG20201Class I
+4K193228Hamilton-G5Hamilton Medical AG20201—
+4K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB20193—
+4K170872Aisys CS2Datex-Ohmeda, Inc.201704
+4K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+4K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+4K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+4K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+4K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+4K123637Hamilton-C3Hamilton Medical AG20124—
+5K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+5K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+5K233486731 Series VentilatorZOLL Medical Corporation20240—
+5K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+5K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator…Maquet Critical Care AB20210Class I
+5K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB20200Class I
+5K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+5K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+5K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+6K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I
+6K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+6K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+6K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+7K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—