Summary for ARTG Entry:
Device Technologies Australia Pty Ltd - Simulator, <specify>
ARTG entry for
Medical Device Included Class 1
Device Technologies Australia Pty Ltd
Locked Bag 521,FRENCHS FOREST, NSW, 2086
ARTG Start Date
Medical Device Class 1
- 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.
Hans Rudolph Inc
8325 Cole Parkway
Shawnee, KS, 66227
United States Of America
1. Simulator, <specify>
Medical device system
15059 Simulator, <specify>
A system that is intended for use as a patient simulation device which allows the user to check the ability
of a single-breath DLco (diffusing capacity of lung for carbon monoxide) for patient testing instrument. This
system is not intended for patient monitoring, treatment or diagnosis.
No Specific Conditions included on Record
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Produced at 09.11.2017 at 09:49:47 AEDT
This is not an ARTG Certificate document.
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