Information system software, application program, cardiology

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

GE Healthcare Australia Pty Ltd

Class:

Class IIa

Manufactured by:

GE Medical Systems Information Technologies 8200 West Tower Avenue, Milwaukee, WI, 53223 United States Of America

Therapeutic area:

44098 - Information system software, application program, cardiology

Therapeutic indications:

This device is a cardiology information system whichis intended to store, access and manage cardiovascular information on adult and pediatric patients. The information consists of measurements, text, and digitized waveforms. This cardiology information system is intended to provide the ability to review and edit electrocardiographic procedures on screen, through the use of reviewing, measuring, and editing tools including ECG serial comparison and interpretive 12-lead analysis. This device is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or facility providing patient care. This cardiology information system is not intended for real-time patient monitoring or for pediatric serial comparison.

Authorization status:

A

Authorization date:

2011-08-22