Electrode, electrocardiograph, single use

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

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Available from:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Class:
Class 1
Authorization status:
Included
Authorization number:
292897

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Public Summary

Summary for ARTG Entry:

292897

Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Electrode, electrocardiograph, single use

ARTG entry for

Medical Device Included Class 1

Sponsor

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Postal Address

Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000

Australia

ARTG Start Date

17/08/2017

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

Heart Test Laboratories Inc dba Heart Sciences

1301 Solana Blvd Bldg 1 Suite 1527

Westlake, Texas, 76262

United States Of America

Products

1. Electrode, electrocardiograph, single use

Product Type

Single Device Product

Effective date

17/08/2017

GMDN

35035 Electrode, electrocardiograph, single use

Intended purpose

The MyoVista Center Post Electrodes are a proprietary single-use disposable designed to provide

consistent, high quality signal capture for exclusive use with MyoVista hsECG device.

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 01.12.2017 at 11:20:00 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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