Australia TGA ARTG recordSleep disorder interpretive software, patient-use
Australia TGA ARTG Registered Device · Resmed Pty Ltd · ResMed Corp · Class IIa · Started November 22, 2022
Good Name: Resmed Pty Ltd - Sleep disorder interpretive software, patient-use
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- November 22, 2022
- Effective Date
- November 22, 2022
- Name
- Resmed Pty Ltd
- Name
- ResMed Corp
- Country
- United States of America
- Address
- 9001 Spectrum Center Blvd, San Diego, CA, 92123
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.
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.