Sleep assessment device

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

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Available from:
Resmed Limited
Class:
(Export Only) Class 1
Authorization number:
291278

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Public Summary

Summary for ARTG Entry:

291278

Resmed Limited - Sleep assessment device

ARTG entry for

Medical Device Included (Export Only) Class 1

Sponsor

Resmed Limited

Postal Address

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

Australia

ARTG Start Date

10/07/2017

Product category

Medical Device Class 1

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

Resmed Limited

1 Elizabeth Macarthur Drive

BELLA VISTA, NSW, 2153

Australia

Products

1. Sleep assessment device

Product Type

Single Device Product

Effective date

10/07/2017

GMDN

33843 Sleep assessment device

Intended purpose

A device for measuring and recording physiological signals for use in the assessment of sleep-related

breathing disorders. It is intended for use by trained clinicians or end users, in both inpatient and

outpatient environments.

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 03.11.2017 at 01:00:03 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

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