510(k) Report

Devices descending from K023366

134 later devices reach Datex-Ohmeda 7900 Ventilator Enhancements through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K112006Hamilton-TC1Hamilton Medical AG201213—
+6K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+6K102525Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc.20103—
+7K233452Vivo 45 LSBreas Medical AB202501
+7K180295Hamilton-G5Hamiton Medical AG20192—
+7K170872Aisys CS2Datex-Ohmeda, Inc.201704
+7K161450Hamilton-C3Hamilton Medical AG201732
+7K160665FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40Maquet Critical Care AB20171—
+7K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+7K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+7K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+7K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+7K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+7K122438Hamilton-MR1Hamilton Medical AG201311
+7K123637Hamilton-C3Hamilton Medical AG20124—
+7K120574Hamilton-C1Hamilton Medical AG20123—
+7K120670Hamilton-T1Hamilton Medical AG201211Class I
+7K103345Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc.20112—
+8K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I
+8K210384Carescape R860Datex-Ohmeda, Inc.20210—
+8K201306Hamilton-C3Hamilton Medical AG20210Class I
+8K201658Hamilton-C6Hamilton Medical AG20201Class I
+8K193228Hamilton-G5Hamilton Medical AG20201—
+8K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemMaquet Critical Care AB20200Class I
+8K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+8K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+8K153046Hamilton-MR1Hamilton Medical AG20160Class I
+8K131562Breathe Niov Ventilation SystemBreathe Technologies20141—
+9K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+9K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+9K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+9K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+9K152664TAV SystemNew Aera, Inc.20160—
+10K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—