Electrocardiograph, Holter analyser, software
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
09-11-2017
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Available from:
Cardioscan Services Pty Ltd
Class:
Class IIa
Manufactured by:
Biomedical Instruments Co Ltd Room 805 Western Section Huatai Building Xiangmei Road, Futain District, Shenzhen, 518034 China
Therapeutic area:
41651 - Electrocardiograph, Holter analyser, software
Therapeutic indications:
The analysis software is intended to scan, analyse ambulatory ECG data and generate an analytical report, which serves as a reference for clinical diagnosis by physicians.
Authorization status:
A
Authorization date:
2014-02-12
