Summary for ARTG Entry:
Integra Neurosciences Pty Ltd - Integra Licox PtO2 and Temperature Monitor - Patient monitor,
ARTG entry for
Medical Device Included Class IIb
Integra Neurosciences Pty Ltd
Unit 3 / 24-30 Winterton Road,CLAYTON, VIC, 3168
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.
Integra LifeSciences (Ireland) Ltd
IDA Business and Technology Park Sragh
Tullamore, County Offaly,
1. Integra Licox PtO2 and Temperature Monitor - Patient monitor, multiparameter
Medical device system
33586 Single-patient physiologic monitoring system
The Integra Licox PtO2 and Temperature Monitor measures oxygen partial pressure (PtO2) and
temperature in brain tissue and these paramters are used as an aid in determination of the perfusion
status of brain tissue.
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 02:33:34 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