Electrode

Main information

  • Trade name:
  • Electrode, electrocardiograph, single use
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Electrode, electrocardiograph, single use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216560
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216560

Zoll Medical Australia Pty Ltd - Electrode, electrocardiograph, single use

ARTG entry for

Medical Device Included Class 1

Sponsor

Zoll Medical Australia Pty Ltd

Postal Address

Unit 10/39 Herbert Street,ST LEONARDS, NSW, 2065

Australia

ARTG Start Date

25/10/2013

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

Zoll Medical Corporation

269 Mill Road

Chelmsford, MA, 01824-4105

United States Of America

Products

1. Electrode, electrocardiograph, single use

Product Type

Single Device Product

Effective date

25/10/2013

GMDN

35035 Electrode, electrocardiograph, single use

Intended purpose

A single use non-sterile device applied to the surface of the body to transmit electrical signals on the body

surface to a processor. A graphic display of the electrical activity of the heart is obtained recorded on an

electroradiograph (ECG).

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 04:52:25 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