Otoacoustic emission system, battery-powered

Australia - English - Department of Health (Therapeutic Goods Administration)

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Welch Allyn Australia Pty Limited
Class IIa
Authorization status:
Authorization number:

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Public Summary

Summary for ARTG Entry:


Welch Allyn Australia Pty Limited - Otoacoustic emission system, battery-powered

ARTG entry for

Medical Device Included Class IIa


Welch Allyn Australia Pty Limited

Postal Address

PO Box 6637,Macquarie Park, NSW, 2113


ARTG Start Date


Product category

Medical Device Class IIa



Approval area

Medical Devices


- 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.




Diagnostic Group LLC DBA Grason-Stadler

10395 West 70th Street

Eden Prairie, MN, 55344

United States Of America


1. Otoacoustic emission system, battery-powered

Product Type

Single Device Product

Effective date



58019 Otoacoustic emission system, battery-powered

Intended purpose

The OAE Hearing Screener is indicated for testing of cochlear function in infants, children, and adults by

measuring otoacoustic emissions (OAEs). The OAEs are generated by a series of clicks that are directed

into the ear canal.

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

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Produced at 03.11.2017 at 03:34:38 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

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