Summary for ARTG Entry:
Interacoustics Pty Ltd - Stimulator, caloric, vestibular function
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
1. Stimulator, caloric, vestibular function
Single Device Product
34891 Stimulator, caloric, vestibular function
A stimulator that applies heat stimuli in the form of a stream of air or water into the ear canal. Vestibular
function stimulators consist of an irrigation system that include a pump, valves, heaters, regulators to
control the rate of flow and temperature of the medium. The stimulation of the semicircular canal produces
involuntary eye movements which are measured using a nystagmograph. It is used for vestibular function
testing for assessing the patient's balance system.
No Specific Conditions included on Record
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