Information system software, application program, cardiology

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Compra

Commercializzato da:

GE Healthcare Australia Pty Ltd

Classe:

Class IIa

Prodotto da:

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

Area terapeutica:

44098 - Information system software, application program, cardiology

Indicazioni terapeutiche:

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.

Stato dell'autorizzazione:

A

Data dell'autorizzazione:

2011-08-22

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