Summary for ARTG Entry:
Interacoustics Pty Ltd - Electronystagmograph
ARTG entry for
Medical Device Included Class IIa
Interacoustics Pty Ltd
PO Box 238,NORTH RYDE BC, NSW, 1670
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.
Assens, , 5610
Medical device system
A graphic recorder used for detecting the electrical potential caused by eye movements. This recorders
include an electrode for each eye and one on the
forehead (multichannel recording) for measuring the potential from both eyes simultaneously, or
repositioning of the electrodes before each test for single
channel recording. Electronystagmographs are used for detecting multiple sclerosis, vestibular
dysfunctions, the presence of drugs and other specific disorders
characterized by involuntary eye movement (nystagmus).
No Specific Conditions included on Record
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Produced at 10.11.2017 at 05:30:13 AEDT
This is not an ARTG Certificate document.
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