Patient data recorder, long-term, electrocardiograph

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Disponible depuis:

Microport Crm Pty Ltd

classe:

Class IIa

Fabriqué par:

MicroPort CRM S.r.l Via Crescentino sn, Saluggia, VC, 13040 Italy

Domaine thérapeutique:

35162 - Patient data recorder, long-term, electrocardiograph

indications thérapeutiques:

Digital ECG Holter recorders intended for multi day ambulatory ECG recording (at 200Hz sampling rate). The devices are used to monitor and diagnose cardiac rhythm disorders through analysis of ECG recordings. Devices may record relevant physiologic signals for evaluating Sleep Apnoea Syndrome. Data is recorded on a removable SD card which is used for clinical analysis.

Statut de autorisation:

A

Date de l'autorisation:

2014-08-05