510(k) Report

Devices descending from K081842

37 later devices reach Engstrom Carestation, Engstrom Pro through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103803Hamilton-G5Hamilton Medical AG201114Class I
+1K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C201021—
+2K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+2K131774Hamilton-G5Hamilton Medical AG201310Class 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
+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
+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—
+4K210384Carescape R860Datex-Ohmeda, Inc.20210—
+4K201306Hamilton-C3Hamilton Medical AG20210Class I
+4K201658Hamilton-C6Hamilton Medical AG20201Class I
+4K193228Hamilton-G5Hamilton Medical AG20201—
+4K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+4K170872Aisys CS2Datex-Ohmeda, Inc.201704
+4K153046Hamilton-MR1Hamilton Medical AG20160Class I
+4K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+4K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+4K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+5K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+5K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+5K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+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
+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—