Device Dossier

Patient monitor module, electroencephalograph

Device Dossier for Patient monitor module, electroencephalograph (Patient monitor module, electroencephalograph, Class IIb, sponsor GE Healthcare). ARTG…

Intended purpose

This device is intended to be used in a multiparameter patient monitor, for the detection and recording of electroencephalogram (EEG) signals which are caused by the electrical activity of the brain and detected via electrodes affixed to the patient's forehead or scalp. Auditory evoked potential signals (AEP) may also be registered. This module is intended to be used during anaesthesia and critical care treatment.

TGA Public Summary