Device Dossier

Multichannel electrocardiograph, interpretive, home-use

Device Dossier for Multichannel electrocardiograph, interpretive, home-use (Multichannel electrocardiograph, interpretive, home-use, Class IIa, sponsor…

Intended purpose

This Easy ECG Monitor is intended for measuring and recording the ECG signal and average heart rate of adult patient. It is applicable for use in clinics and homes, and convenient to operate by the patients themselves. This device is not an ECG monitor used in clinical institution or hospital, but is used for spot-check purpose ONLY. It can not be used to substitute the normal ECG examination or real time monitoring. The measurement results are useful reference for the doctor, but do not make direct diagnostic or analytical decision based on the information provided by this device.

TGA Public Summary