Sleep assessment device
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
09-11-2017
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Available from:
Digital Dental Resources Pty Ltd
Class:
Class IIa
Manufactured by:
Braebon Medical Corporation 1-100 Schneider Road, Kanata, ON, K2K 1Y2 Canada
Therapeutic area:
33843 - Sleep assessment device
Therapeutic indications:
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.
Authorization status:
A
Authorization date:
2014-02-07
