510(k) Report

Devices descending from K980642

112 later devices reach EVITA 4 (8411900) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+6K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+7K233486731 Series VentilatorZOLL Medical Corporation20240—
+7K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+7K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+7K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+7K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+8K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I
+8K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+8K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+8K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+9K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—