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Clinical data collection/management information application software - ARTG 384101

Access comprehensive regulatory information for Clinical data collection/management information application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 384101 and sponsored by Resmed Pty Ltd, manufactured by ResMed Corp in United States of America. The device registration started on February 16, 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.

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Class IIa
ARTG 384101
Class IIa
Clinical data collection/management information application software
ARTG ID: 384101
Good Name: Resmed Pty Ltd - Clinical data collection/management information application software
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Intended Purpose

AirView is a web-based solution for healthcare specialists intended to assist in the diagnosis of sleep disordered breathing in adult patients through analysis of data recorded by an AirView compatible home sleep test device. The device transfers and displays usage and therapeutic information that has been transmitted remotely from the patientโ€™s therapy device. It is intended to support the standard follow-up care of patients who have been prescribed a compatible ResMed therapy device for the treatment of obstructive sleep apnea or respiratory insufficiency. AirView also provides remote settings capabilities for non-life support devices only.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
384101
Start Date
February 16, 2022
Effective Date
February 16, 2022
Sponsor
Manufacturer
Country
United States of America
Address
9001 Spectrum Center Blvd, San Diego, CA, 92123