Summary for ARTG Entry:
MD Solutions Australasia Pty Ltd - Barostat
ARTG entry for
Medical Device Included Class IIa
MD Solutions Australasia Pty Ltd
Unit 1/16-18 Tennyson Street,WILLIAMSTOWN NORTH, VIC, 3016
ARTG Start Date
Medical Device Class IIa
- 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.
G & J Electronics Inc
6 Dornfell Street
Toronto, Ontario, M2R 2Y6
Medical device system
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.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 04:31:30 AEDT
This is not an ARTG Certificate document.
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