Cardiac mapping system workstation

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

Buy It Now

Available from:
Biotronik Australia Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
324033

Public Summary

Summary for ARTG Entry:

324033

Biotronik Australia Pty Ltd - Cardiac mapping system workstation

ARTG entry for

Medical Device Included Class IIb

Sponsor

Biotronik Australia Pty Ltd

Postal Address

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

Australia

ARTG Start Date

25/09/2019

Product category

Medical Device Class IIb

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. Cardiac mapping system workstation

Product Type

Single Device Product

Effective date

25/09/2019

GMDN

31742 Cardiac mapping system workstation

Intended purpose

The console connects to the different elements of an EP mapping system to format and transmit signals to

the computer for display and analysis. It contains all electronics for interfacing with patient-contacting

devices required by the system. It also provides patient isolation, signal filtering, signal digitization, and

transmission of ultrasound and localization signals. The Console includes an internal auxiliary power

supply to provide clinical grade ECG output signals in the event of a power outage or other disruption of

service.

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 03:48:50 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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