Patient monitor, electrocardiograph
Access comprehensive regulatory information for Patient monitor, electrocardiograph in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Cardioscan Services Pty Ltd, manufactured by Edan Instruments Inc in China. The device registration started on March 20, 2019.
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The device is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the interpreted ECG with measurements and interpretive statements is offered to clinicians a on an advisory basis only.