Device Category Dossier

Patient data recorder, long-term, electrocardiograph

Device Category Dossier for Patient data recorder, long-term, electrocardiograph. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Holter systems comprise a recorder and analysis software intended for ambulatory electrocardiogram monitoring , recording multiple channels of electrocardiographic data continuously for periods ranging from days to weeks . These devices detect arrhythmias in ambulatory patients and are intended for use under the supervision of a physician or those knowledgeable in electrocardiogram morphology, rhythm, and arrhythmia .