Summary for ARTG Entry:
Digital Dental Resources Pty Ltd - Sleep assessment device
ARTG entry for
Medical Device Included Class IIa
Digital Dental Resources Pty Ltd
PO Box 603,PADDINGTON, QLD, 4064
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.
Braebon Medical Corporation
1-100 Schneider Road
Kanata, ON, K2K 1Y2
1. Sleep assessment device
Single Device Product
33843 Sleep assessment device
A device intended for the registration of physiological signals from a patient while sleeping and used for
assessing and aiding in the treatment of sleeping disorders, e.g. insomnia, snoring or sleep apnoea.
Sensors include oxygen saturation, heart rate, pressure flow, chest and abdomen movement, body
position, EKG, EMG and audio levels. The device is mobile and can be used in a patient's home or a
medical or dental environment.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 05:47:42 AEDT
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