ARTG 461366Tissue saturation oximeter
ARTG ID: 461366 · Edwards Lifesciences Pty Ltd · Edwards Lifesciences LLC · Class IIb · Started August 29, 2024
Good Name: Edwards Lifesciences Pty Ltd - Tissue saturation oximeter
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 461366
- Start Date
- August 29, 2024
- Effective Date
- August 29, 2024
- Country
- United States of America
- Address
- One Edwards Way, Irvine, California, 92614
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.
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.