Device Dossier

Electrocardiograph, general-purpose

Device Dossier for Electrocardiograph, general-purpose (Electrocardiograph, general-purpose, Class IIa, sponsor MGC Diagnostics). ARTG record, intended…

Intended purpose

A device that is used to detect, register, and record the electrical signals produced through the activity of the heart and to reproduce these signals as an electrocardiogram (ECG), typically in the form of a print out, but also on a display or in digital media for further use. The device may also include a variety of other respiratory functions such as spiromettry and feature single or multichannel recording, data storage capabilities, interpretative capabilities, as well as, testing during passive or active participation of the patient.

TGA Public Summary