Information system software, application program, cardiology

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Kupite ga zdaj

Javno poročilo o oceni Javno poročilo o oceni (PAR)
13-11-2017

Dostopno od:

GE Healthcare Australia Pty Ltd

Razred:

Class IIa

Izdeluje:

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

Terapevtsko območje:

44098 - Information system software, application program, cardiology

Terapevtske indikacije:

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 dovoljenje:

A

Datum dovoljenje:

2011-08-22

Opozorila o iskanju, povezana s tem izdelkom