Multiple

Main information

  • Trade name:
  • Multiple physiological parameter simulation kit
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Multiple physiological parameter simulation kit
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218195
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218195

GE Healthcare Australia Pty Ltd - Multiple physiological parameter simulation kit

ARTG entry for

Medical Device Included Class 1

Sponsor

GE Healthcare Australia Pty Ltd

Postal Address

PO Box 5079,PARRAMATTA DC, NSW, 2150

Australia

ARTG Start Date

6/12/2013

Product category

Medical Device Class 1

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

GE Medical Systems Information Technologies

8200 West Tower Avenue

Milwaukee, WI, 53223

United States Of America

Products

1. Multiple physiological parameter simulation kit

Product Type

Single Device Product

Effective date

6/12/2013

GMDN

60264 Multiple physiological parameter simulation kit

Intended purpose

This device is an accessory of the CardioLab system. It connects to the CardioLab Amplifier and is a

physiological simulator that plays back waveforms that emulate data types (Invasive Pressure, Intracardiac

ECG, Surface ECG, Stimulation). The simulated waveform data is intended to be used for training, testing,

development, troubleshooting, and demonstration of the CardioLab system.

The simulator is not intended to be used for calibration of other devices.

The simulator can be used in various types of environments including both clinical and non-clinical settings

where a CardioLab system and CardioLab Amplifier are present. However, the simulator is not intended to

be used while a patient is present and connected to the CardioLab system.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 11:28:09 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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