Device Dossier

Electrocardiograph, Holter analyser, software

Device Dossier for Electrocardiograph, Holter analyser, software (Electrocardiograph, Holter analyser, software, Class IIa, sponsor Welch Allyn). ARTG…

Intended purpose

The device is intended to acquire, automatically analyze, edit, review, report and store prerecorded ECG data of patients that have been connected to compatible recorders. The cardiac data and analysis provided by the device is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various cardiac rhythm patterns

TGA Public Summary