510(k) Report

Devices descending from K200015

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260098ePM 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
+1K253170uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—