Amplifier, physiological signal

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

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Available from:
Atris Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
292816

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Public Summary

Summary for ARTG Entry:

292816

Atris Pty Ltd - Amplifier, physiological signal

ARTG entry for

Medical Device Included Class IIa

Sponsor

Atris Pty Ltd

Postal Address

19 Duchess Avenue,RODD POINT, NSW, 2046

Australia

ARTG Start Date

15/08/2017

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

Neurosoft Ltd

Voronin str 5

Ivanovo, , 153032

Russian Federation

Products

1. Amplifier, physiological signal

Product Type

Medical device system

Effective date

15/08/2017

GMDN

32521 Amplifier, physiological signal

Intended purpose

Amplifier system designed for use in the recording of routine EEG overnight sleep/EEG (PSG,

Polysomnography)and other neurophysiological monitoring application

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 07:07:01 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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