Electrocardiograph, general-purpose
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
16-11-2017
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Available from:
Vyaire Medical Pty Ltd
Class:
Class IIa
Manufactured by:
Vyaire Medical GmbH Leibnizstrasse 7, Hochberg, Germany, 97204 Germany
Therapeutic area:
30004 - Electrocardiograph, general-purpose
Therapeutic indications:
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, (voltage versus time) as an electrocardiogram (ECG). The device is primarily used in a system with sleep assessment/apnoea devices.
Authorization status:
A
Authorization date:
2008-11-19
