Sleep

Main information

  • Trade name:
  • Sleep assessment device
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Sleep assessment device
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218555
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218555

USL Medical Pty Limited - Sleep assessment device

ARTG entry for

Medical Device Included Class IIa

Sponsor

USL Medical Pty Ltd

Postal Address

PO Box 1664,NORTH SYDNEY, NSW, 2059

Australia

ARTG Start Date

14/12/2013

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

Lowenstein Medical Technology GmbH Co Kg

Kronsaalsweg 40

, Hamburg, 22525

Germany

Products

1. Sleep assessment device

Product Type

Single Device Product

Effective date

14/12/2013

GMDN

33843 Sleep assessment device

Intended purpose

It is a data recording system for registering, recording and storing biosignals. It is used to identify

sleep-related respiratory disorders and associated risk factors, as well as other sleep disorders (e.g. PLM),

to support diagnosis and for making therapy settings and checks

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 10:05:32 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

There are no safety alerts related to this product.

11-10-2018

October is #SIDSAwarenessMonth.  Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS. Make sure your baby is #safetosleep at  https://women.smokefree.gov/  via @FDATobaccopic.twitter.com/i37QX61Bb

October is #SIDSAwarenessMonth. Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS. Make sure your baby is #safetosleep at https://women.smokefree.gov/  via @FDATobaccopic.twitter.com/i37QX61Bb

October is #SIDSAwarenessMonth. Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS. Make sure your baby is #safetosleep at https://women.smokefree.gov/  via @FDATobacco pic.twitter.com/i37QX61Bb7

FDA - U.S. Food and Drug Administration