Sleep assessment device
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
15-11-2017
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Available from:
BMedical Pty Ltd
Class:
Class IIa
Manufactured by:
Advanced Brain Monitoring Inc 2237 Faraday Avenue Suite 100, Carlsbad, CA, 92008 United States Of America
Therapeutic area:
33843 - Sleep assessment device
Therapeutic indications:
The device is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, transmit and display physiological signals during wake or sleep periods and is intended for use for the diagnostic evaluation by a physician and to be used under the supervision of a clinician to assess sleep quality and score sleep disordered breathing events in adults only.
Authorization status:
A
Authorization date:
2010-02-15
