510(k) Report

Devices descending from K072286

8 later devices reach Bis Eeg Vista Monitor System and Bisx through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.20260—
+1K230693BIS™ Advance Monitoring SystemCovidien, LLC20241—
+1K213273Brain Anesthesia Response Monitor (Bar Monitor)Cortical Dynamics, Ltd.20230—
+1K202621NeuroSENSE Monitoring System, Model NS-901Neurowave Systems, Inc.20210—
+1K131898A Series and Q Series Patient MonitorsGuangdong Biolight Meditech Co., Ltd.20142—
+2K260907BIS™ Advance pEEG ModuleCovidien LP20260—
+2K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+3K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001