510(k) Report

Devices descending from K123074

7 later devices reach Imec, Ipm and Beneview T1 Patient Monitors through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+1K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+1K132662Passport Series Patient MonitorsShenzhen Mindray Biomedical Electronics Co., Ltd.20141—
+2K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+2K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+3K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+4K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007