Device Dossier

Patient data recorder, long-term, electrocardiograph

Device Dossier for Patient data recorder, long-term, electrocardiograph (Patient data recorder, long-term, electrocardiograph, Class IIa, sponsor…

Intended purpose

Digital ECG Holter recorders intended for multi day ambulatory ECG recording (at 200Hz sampling rate). The devices are used to monitor and diagnose cardiac rhythm disorders through analysis of ECG recordings. Devices may record relevant physiologic signals for evaluating Sleep Apnoea Syndrome. Data is recorded on a removable SD card which is used for clinical analysis.

TGA Public Summary