Details
Device typeSleep disorder interpretive software, professional-only: An interpretive software program intended to be used exclusively by healthcare professionals to collect and analyse patient physiological data during sleep and publish reports to assist diagnosis of sleep disorders (e.g., insomnia, sleep apnoea). It is typically used as part of a polysomnography study using a wide range of data of [e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement].
FDA categoryAutomatic Event Detection Software For Polysomnograph With Electroencephalograph
Device ID15694311112099
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information