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

A device used for a minimum of 24 hours for registration of a patient's heart activity, which is connected to, and carried by the patient during the period of recording. The signals are stored on a digital medium (no moving parts). The recording is analysed at the hospital or cardiologist surgery using a computer.

TGA Public Summary