Device Dossier

Alice Sleep System - Sleep assessment device

Device Dossier for Alice Sleep System - Sleep assessment device (Sleep assessment device, Class IIa, sponsor Philips Electronics). ARTG record, intended…

Intended purpose

The Diagnostic Systems are single-patient use, polysomnography system that is intended to record, display and print physiological information for clinicans or physicians. Similar in application to the use of a traditional paper-based polygraph recorder. The device will be used in hospitals, institutions, sleep center or clinics, or other test environments where adults or infant patients require the documentation of various sleep or other physiological disorders.

TGA Public Summary