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 AMA…

Intended purpose

The device is used for the long-term registration of a patient's heart activity. The device is connected to and carried by the patient during the period of recording. The signals from the device are storted on a digital medium (SD Card). The recording from the device can be analysed in real-time via bluetooth wireless technology, or at a later period using holter analysis software.

TGA Public Summary