Patient monitor module, interface

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

Buy It Now

Available from:
Biotronik Australia Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
323080

Public Summary

Summary for ARTG Entry:

323080

Biotronik Australia Pty Ltd - Patient monitor module, interface

ARTG entry for

Medical Device Included Class 1

Sponsor

Biotronik Australia Pty Ltd

Postal Address

Suite 2 Level 4 Building 2,20 Bridge Street,PYMBLE, NSW, 2073

Australia

ARTG Start Date

12/09/2019

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

Acutus Medical Inc

2210 Faraday Avenue Suite 100

, Carlsbad, 92008

United States Of America

Products

1. Patient monitor module, interface

Product Type

Single Device Product

Effective date

12/09/2019

GMDN

36862 Patient monitor module, interface

Intended purpose

It provides connection to the auxiliary catheters used during the procedure, amplification of collected

signals and transfers these signals for display.

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 04:28:10 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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