Delica

Main information

  • Trade name:
  • Delica Series - Ultrasound system, non-imaging, Doppler blood-flow measurement
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Delica Series - Ultrasound system, non-imaging, Doppler blood-flow measurement
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220543
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220543

Pulsewave Pty Ltd - Delica Series - Ultrasound system, non-imaging, Doppler blood-flow measurement

ARTG entry for

Medical Device Included Class IIa

Sponsor

Pulsewave Pty Ltd

Postal Address

20 Manakin Avenue,BURLEIGH HEADS, QLD, 4220

Australia

ARTG Start Date

27/02/2014

Product category

Medical Device Class IIa

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Shenzhen Delicate Electronics Co Ltd

6C Block 8 Nanyou Tian-an Industrial Area

Dengliang Road

Nanshan District, Shenzhen, 518054

China

Products

1. Delica Series - Ultrasound system, non-imaging, Doppler blood-flow measurement

Product Type

Medical device system

Effective date

27/02/2014

GMDN

40759 Ultrasound system, non-imaging, Doppler blood-flow measurement

Intended purpose

A multifunctional Ultrasound Doppler intended to be used to monitor, display and store the results of

ultrasonic doppler investigations of the cranial vessels.

Specific Conditions

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.

Public Summary

Page 1 of

Produced at 10.11.2017 at 03:48:32 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