Sleep disorder interpretive software, patient-use
Access comprehensive regulatory information for Sleep disorder interpretive software, patient-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Resmed Pty Ltd, manufactured by ResMed Corp in United States of America. The device registration started on November 22, 2022.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
This device is intended as a pre-screening device used to analyse breathing patterns and snore sounds during sleep to assess the risk of obstructive sleep apnea (OSA). It is intended to be used by adults 18 years old and above in a non-clinical environment, such as the person's home. The device is not intended to provide a diagnosis and is not intended to substitute for a sleep study or medical advice.