Flowmeter

Main information

  • Trade name:
  • Flowmeter, blood, ultrasonic
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Flowmeter, blood, ultrasonic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221438
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221438

Bosco Medical Australia - Flowmeter, blood, ultrasonic

ARTG entry for

Medical Device Included Class IIa

Sponsor

Bosco Medical Australia

Postal Address

2/49 Borthwick Avenue,MURARRIE, QLD, 4172

Australia

ARTG Start Date

19/03/2014

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

ATYS

17 Parc D'Arbora

, Soucieu en Jarrest, 69510

France

Products

1. Flowmeter, blood, ultrasonic

Product Type

Single Device Product

Effective date

19/03/2014

GMDN

10432 Flowmeter, blood, ultrasonic

Intended purpose

Non invasive doppler device for the evaluation of various blood flow related parameters in the arteries and

veins.

It is used for the non-invasive evaluation of peripheral vascular pathology and venous insufficiency.

Available tests: measurement of systolic blood pressure, Doppler blood flow recording, measurement of

the blood velocities, pulse volume recording (PVR), photo-plethysmograph (PPG) recording and the

measurement of venous refilling time.

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 01:04:26 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