Device typePolysomnography analyser: A mains electricity (AC-powered) device designed to record and interpret a variety of physiologic functions during sleep to evaluate sleep/sleep-related disorders (e.g., insomnia, hypersomnia, apnoea). It typically performs electroencephalography, electrocardiography, electro-oculography, electromyography, and respiration, temperature, and pulse oximetry readings. It may also provide audiovisual information about the sleeping patient for behavioral analysis and other measurements (e.g., gastric reflux, bedwetting). The device includes electrodes, measuring instruments, samplers, filters, amplifiers, and appropriate software for processing data and providing patient diagnoses.
FDA categoryAutomatic event detection software for polysomnograph with electroencephalograph
Device ID00606959045262
Catalog number1082463
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information