510(k) Report

Devices descending from K191769

5 later devices reach ePM Series Patient monitors through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211475Vital Signs MonitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20211—
+1K200015ePM Series Patient monitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20202—
+2K260098ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.202601
+2K253170uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+2K221267VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs MonitorShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20220—