Defibrillator/pacemaker
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
09-11-2017
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Available from:
Device Technologies Australia Pty Ltd
Class:
Class IIb
Manufactured by:
CU Medical Systems Inc 130-1 Donghwagongdan-ro Munmak-eup, Wonju-si, Gangwon-do Korea - Republic of
Therapeutic area:
17882 - Physiologic-monitoring defibrillation system
Therapeutic indications:
A defibrillator system intended for use on patients that are exhibiting the symptoms of sudden cardiac arrest by applying an electric shock to resuscitate the patient, correct arrhythmias or temporarily pace.
Authorization status:
A
Authorization date:
2014-03-17
