510(k) Report

Devices descending from K152902

6 later devices reach Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+1K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+1K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+1K160746CARDIOLINE touchECGCardioline S.P.A20160—
+2K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+3K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—