Computer

Main information

  • Trade name:
  • Computer, cardiac physiology
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Computer, cardiac physiology
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220461
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220461

InMed Pty Ltd - Computer, cardiac physiology

ARTG entry for

Medical Device Included Class IIa

Sponsor

InMed Pty Ltd

Postal Address

PO Box 630,WINSTON HILLS, NSW, 2153

Australia

ARTG Start Date

25/02/2014

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

Labtech Kft

H-4031 Debrecen Vag ut 4

Hungary

Products

1. Computer, cardiac physiology

Product Type

Medical device system

Effective date

25/02/2014

GMDN

34972 Computer, cardiac physiology

Intended purpose

12 lead ECG system for rest and stress testing.

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 04:00:37 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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Scientific guideline: Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

This document provides a standard approach to be used across the European Union in the analysis of residue depletion data for the purpose of establishing withdrawal periods for edible tissues. Emphasis has been put on a statistical approach. As the method of first choice, a linear regression technique is recommended. A computerised version of the method described is available: Updated application software: withdrawal time calculation for tissues. Read together with the explanatory note on updated applica...

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Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Heat processing of food gives rise to a plethora of chemical compounds whose toxicological effects are largely unknown. Due to a general lack of experimental toxicological data, assessing the risks associated with the consumption of these substances remains a challenge. Computer models that allow for an in silico prediction of physicochemical and toxicological characteristics, may be able to fill current data gaps and facilitate the risk assessment of toxico...

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