Multiple physiological parameter simulation kit - ARTG 299280
Access comprehensive regulatory information for Multiple physiological parameter simulation kit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 299280 and sponsored by GE Healthcare Australia Pty Ltd, manufactured by GE Medical Systems Information Technologies in United States of America. The device registration started on February 02, 2018.
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 simulator is an accessory of the CardioLab system. It connects to the CardioLab Amplifier and is intended as a physiological simulator that plays back waveforms that emulate the following data types: • Invasive Pressure • Intracardiac ECG • Surface ECG • Stimulation The simulated waveform data is intended to be used for training, testing, development, troubleshooting, and demonstration of the CardioLab system. The simulator is not intended to be used for calibration of other devices. The simulator can be used in various types of environments including both clinical and non-clinical settings where a CardioLab system and CardioLab Amplifier are present. However, the simulator is not intended to be used while a patient is present and connected to the CardioLab system. When operated by a customer (external to GE), the simulator is intended to be operated under the direct supervision of licensed healthcare professionals who are responsible for interpreting the data, which may include: physicians, nurses, and various specialized technicians.