Summary for ARTG Entry:
Designs for Vision Aust Pty Ltd - Electroretinograph
ARTG entry for
Medical Device Included Class IIa
Designs for Vision Aust Pty Ltd
PO Box 77,CAMPERDOWN, NSW, 2050
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.
LKC Technologies Inc
Suite 222 / 2 Professional Drive
Gaithersburg, MD, 20879
United States Of America
Single Device Product
An ophthalmic device intended to be used to record the changes in electric potential on or near the surface
of the cornea to a reference distal point on the body, following stimulation of the retina by light i.e. flashes
of white light.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:12:01 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.
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