510(k) Report

Devices descending from K170876

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+1K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+2K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—