Information system software, application program, cardiology

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Beli sekarang

Laporan Penilaian Awam Laporan Penilaian Awam (PAR)
13-11-2017

Boleh didapati daripada:

GE Healthcare Australia Pty Ltd

Kelas:

Class IIa

Dikeluarkan oleh:

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

Kawasan terapeutik:

44098 - Information system software, application program, cardiology

Tanda-tanda terapeutik:

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.

Status kebenaran:

A

Tarikh kebenaran:

2011-08-22

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