Pulse

Main information

  • Trade name:
  • Pulse oximeter, battery-powered
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Pulse oximeter, battery-powered
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221819
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221819

Ferno Australia Pty Ltd - Pulse oximeter, battery-powered

ARTG entry for

Medical Device Included Class IIb

Sponsor

Ferno Australia Pty Ltd

Postal Address

PO Box 5210,BRENDALE, QLD, 4500

Australia

ARTG Start Date

31/03/2014

Product category

Medical Device Class IIb

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

Acare Technology Co Ltd

6F-6 No 5 Wuquan 1st Road

Xinzhuang District, New Taipei City,

Taiwan (Province of China)

Products

1. Pulse oximeter, battery-powered

Product Type

Single Device Product

Effective date

31/03/2014

GMDN

45607 Pulse oximeter, battery-powered

Intended purpose

A pulse oximeter intended for the noninvasive measurement of SpO2 oxygen saturation and blood pulse

rate.

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 09.11.2017 at 11:43:00 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

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