Interpretive multichannel electrocardiograph
Access comprehensive regulatory information for Interpretive multichannel electrocardiograph in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by GE Healthcare Australia Pty Ltd, manufactured by GE Medical Systems Information Technologies in United States of America. The device registration started on November 22, 2017.
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 portable ECG acquisition, analysis and recording system. It is intended to be used under the direct supervision of a licensed healthcare practitioner, and by trained operators in a hospital or medical professional's facility environment as well as used in clinics, physician offices outreach centers. It is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years.