Summary for ARTG Entry:
Philips Electronics Australia Ltd - Portable ventilator, electric
ARTG entry for
Medical Device Included Class IIb
Philips Electronics Australia Ltd
Locked Bag 30,NORTH RYDE BC, NSW, 1670
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.
1001 Murry Ridge Lane
Murrysville, Pennsylvania, 15668 8550
United States Of America
1. Portable ventilator, electric
Single Device Product
47083 Portable ventilator, electric
The device intended to provide non-invasive ventilation intended to provide non-invasive ventilatory
support to treat adult and pediatric patients weighing > 10 kg (22 lbs) with Obstructive Sleep Apnea (OSA)
and Respiratory Insufficiency. It is intended for use in the hospital.
No Specific Conditions included on Record
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Page 1 of
Produced at 10.11.2017 at 02:31:35 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information