Pulse oximeter, battery-powered

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

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Available from:
Oxygen Plus Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
339798

Public Summary

Summary for ARTG Entry:

339798

Oxygen Plus Pty Ltd - Pulse oximeter, battery-powered

ARTG entry for

Medical Device Included Class IIa

Sponsor

Oxygen Plus Pty Ltd

Postal Address

4 Curringa Street, Mansfield, QLD, 4122

Australia

ARTG Start Date

20/07/2020

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

Beijing Choice Electronic Technology Co Ltd

2nd Floor 3rd Floor and Room 410-412 4th

Floor No 2 Building 9 Shuangyuan Road

Shijingshan District, Beijing, 100041

China

Products

1 . Pulse oximeter, battery-powered

Product Type

Single Device Product

Effective Date

20/07/2020

GMDN

45607 Pulse oximeter, battery-powered

Intended Purpose

The fingertip pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial

hemoglobin (SpO2)and Pulse Rate of adult, adolescent and child patients in hospitals, hospital-type facilities and homecare.

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 22.07.2020 at 08:29:23 AEST

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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