510(k) Report

Devices descending from K001646

112 later devices reach Puritan-Bennett 840 Ventilator System with Neomode Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K170872Aisys CS2Datex-Ohmeda, Inc.201704
+7K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+7K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+7K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+8K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+8K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+8K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+8K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+9K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I
+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
+10K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—