Summary for ARTG Entry:
Breathing and Medical - Sleep apnoea face mask, reusable
ARTG entry for
Medical Device Included Class IIa
Breathing and Medical
PO Box 4,WEST RYDE, NSW, 1685
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.
5 Merrill Industrial Drive
Hampton, NH, 03842
United States Of America
1. Sleep apnoea face mask, reusable
Single Device Product
44521 Sleep apnoea face mask, reusable
A device intended to be placed over the nose and mouth and designed to direct ambient air, or oxygen
and air, into the respiratory tract at a higher pressure then ambient air, to provide positive pressure to
improve/enhance the sleep of persons experiencing sleep apnoea.
No Specific Conditions included on Record
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