510(k) Report

Devices descending from K041775

107 later devices reach GE Datex-Ohmeda Engstrom Carestation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+8K152664TAV SystemNew Aera, Inc.20160—
+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—