Device Dossier
Sleep assessment device
Device Dossier for Sleep assessment device (Sleep assessment device, Class IIa, sponsor Temple Medical & Scientific). ARTG record, intended purpose, GMDN…
- GMDN category: Sleep assessment device
Intended purpose
The Wesper Lab is a digital recording device designed to be used under the direction of a physician or trained technician but may be applied by a layperson. Wesper Lab records multiple physiological parameters from a sleeping patient for the purpose of simultaneous or subsequent display of the parameters. The displayed data assists in the identification of sleep apnea by trained personnel. Wesper Lab is intended to be used for adult sleep studies at home or clinical environment. The device does not actively monitor or diagnose the patient and does not issue any alarms.