Pulse oximeter, battery-powered

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Available from:
Resmed Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
322124

Public Summary

Summary for ARTG Entry:

322124

Resmed Limited - Pulse oximeter, battery-powered

ARTG entry for

Medical Device Included Class IIb

Sponsor

Resmed Limited

Postal Address

Regulatory Affairs / 1 Elizabeth Macarthur Drive,BELLA VISTA, NSW, 2153

Australia

ARTG Start Date

21/08/2019

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

Nonin Medical Inc

13700 1st Avenue North

Plymouth, MN, 55441-5443

United States Of America

Products

1. Pulse oximeter, battery-powered

Product Type

Single Device Product

Effective date

21/08/2019

GMDN

45607 Pulse oximeter, battery-powered

Intended purpose

It is a portable photoelectric device intended for transcutaneous measurement and display of blood oxygen

saturation (SpO2). It is for use in hospital, emergency services and home healthcare.

Specific Conditions

© 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 02.11.2019 at 06:21:03 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

Search alerts related to this product

Share this information