510(k) Report

Devices descending from K992608

133 later devices reach Atc Option for Evita 2 Dura and Evita 4 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K240807VM-2000Ventis Medical, Inc.20240—
+6K210384Carescape R860Datex-Ohmeda, Inc.20210—
+6K193586Vivo 45 LSBreas Medical AB20212Class I
+6K193228Hamilton-G5Hamilton Medical AG20201—
+6K172875Astral 100/150Resmed, Ltd.20180Class I
+6K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+6K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc.20124Class I
+6K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+6K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+6K102525Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc.20103—
+7K233452Vivo 45 LSBreas Medical AB202501
+7K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+7K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class I
+7K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+7K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+7K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc.201323
+7K122438Hamilton-MR1Hamilton Medical AG201311
+7K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+7K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+7K103345Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc.20112—
+8K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+8K170872Aisys CS2Datex-Ohmeda, Inc.201704
+8K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+8K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+8K131562Breathe Niov Ventilation SystemBreathe Technologies20141—
+8K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+9K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+9K152664TAV SystemNew Aera, Inc.20160—
+9K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+10K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I
+10K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+10K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+11K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—