Summary for ARTG Entry:
Pulsewave Pty Ltd - Delica Series - Ultrasound system, non-imaging, Doppler blood-flow measurement
ARTG entry for
Medical Device Included Class IIa
Pulsewave Pty Ltd
20 Manakin Avenue,BURLEIGH HEADS, QLD, 4220
ARTG Start Date
Medical Device Class IIa
- 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.
Shenzhen Delicate Electronics Co Ltd
6C Block 8 Nanyou Tian-an Industrial Area
Nanshan District, Shenzhen, 518054
1. Delica Series - Ultrasound system, non-imaging, Doppler blood-flow measurement
Medical device system
40759 Ultrasound system, non-imaging, Doppler blood-flow measurement
A multifunctional Ultrasound Doppler intended to be used to monitor, display and store the results of
ultrasonic doppler investigations of the cranial vessels.
No Specific Conditions included on Record
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