Summary for ARTG Entry:
Pentax Medical Pte Ltd - Endoscopic video image processor
ARTG entry for
Medical Device Included Class 1
Pentax Medical Pte Ltd
Unit 203 / 15 Orion Road,Lane Cove, NSW, 2066
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.
Shinjuku-ku, Tokyo, 161-8525
1. Endoscopic video image processor
Medical device system
18034 Endoscopic video image processor
This electro-medical equipment (Video Processor) is intended to be used for endoscopic diagnosis and
Together, this Video Processor and PENTAX video endoscope may provide optical visualization of, and/or
therapeutic access to, various body cavities, organs and canals.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 12:50:20 AEDT
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