Australia - English - Department of Health (Therapeutic Goods Administration)
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
PO Box 6637,Macquarie Park, NSW, 2113
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.
Diagnostic Group LLC DBA Grason-Stadler
10395 West 70th Street
Eden Prairie, MN, 55344
United States Of America
1. Otoacoustic emission system, battery-powered
Single Device Product
58019 Otoacoustic emission system, battery-powered
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.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 03:34:38 AEDT
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