Tissue saturation oximeter - ARTG 461366
Access comprehensive regulatory information for Tissue saturation oximeter in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 461366 and sponsored by Edwards Lifesciences Pty Ltd, manufactured by Edwards Lifesciences LLC in United States of America. The device registration started on August 29, 2024.
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.
It is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors and relative change in total hemoglobin in individuals at risk for reduced flow or no-flow ischemic states.