Summary for ARTG Entry:
Resmed Limited - Portable ventilator, electric
ARTG entry for
Medical Device Included Class IIb
Regulatory Affairs / 1 Elizabeth Macarthur Drive,BELLA VISTA, NSW, 2153
ARTG Start Date
Medical Device Class IIb
- 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.
1 Elizabeth Macarthur Drive
BELLA VISTA, NSW, 2153
1. Portable ventilator, electric
Single Device Product
47083 Portable ventilator, electric
An electrically-powered device providing continuous or intermittent ventilatory support for patients who
require mechanical ventilation. For use in home, hospital and portable applications for both invasive and
No Specific Conditions included on Record
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Produced at 10.11.2017 at 07:35:53 AEDT
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