Information system software, application program, cardiology

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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공공 평가 보고서 공공 평가 보고서 (PAR)
13-11-2017

제공처:

GE Healthcare Australia Pty Ltd

수업:

Class IIa

Manufactured by:

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

치료 영역:

44098 - Information system software, application program, cardiology

치료 징후:

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.

승인 상태:

A

승인 날짜:

2011-08-22

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