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 categoryAmplifier, Physiological Signal, Automatic Event Detection Software For Polysomnograph With Electroencephalograph, Electrocardiograph, Ambulatory, With Analysis Algorithm, Oximeter, Standard Polysomnograph With Electroencephalograph, Ventilatory Effort Recorder
Device ID00817111021172
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information