Summary for ARTG Entry:
Interacoustics Pty Ltd - Otoacoustic emission system, line-powered
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. Otoacoustic emission system, line-powered
Medical device system
58018 Otoacoustic emission system, line-powered
An instrument used to register and analyse faint sounds from the ear. These sounds can be
spontaneously emitted or brought about by click stimulation (transient evoked emissions) or tone burst
stimulation (distortion product emissions).
No Specific Conditions included on Record
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Produced at 10.11.2017 at 05:29:43 AEDT
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