Barostat

Main information

  • Trade name:
  • Barostat
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Barostat
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216699
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216699

MD Solutions Australasia Pty Ltd - Barostat

ARTG entry for

Medical Device Included Class IIa

Sponsor

MD Solutions Australasia Pty Ltd

Postal Address

Unit 1/16-18 Tennyson Street,WILLIAMSTOWN NORTH, VIC, 3016

Australia

ARTG Start Date

30/10/2013

Product category

Medical Device Class IIa

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

G & J Electronics Inc

6 Dornfell Street

Toronto, Ontario, M2R 2Y6

Canada

Products

1. Barostat

Product Type

Medical device system

Effective date

30/10/2013

GMDN

45569 Barostat

Intended purpose

An electro-pneumatic device used for volume/pressure measurement in the alimentary tract. The device is

intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of

patients with symptoms consistent with gastrointestinal motility disorders. The device, when used with

separately supplied catheters, measures sensory pressures and volumes, yet ensures no energy transfers

to a patient.

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 04:31:30 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