Pulmonary

Main information

  • Trade name:
  • Pulmonary function analysis system, adult
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Pulmonary function analysis system, adult
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220187
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220187

Bird Healthcare Pty Ltd - Pulmonary function analysis system, adult

ARTG entry for

Medical Device Included Class IIa

Sponsor

Bird Healthcare Pty Ltd

Postal Address

1/11 Sabre Drive,PORT MELBOURNE, VIC, 3207

Australia

ARTG Start Date

15/02/2014

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

Thorasys Thoracic Medical Systems Inc

6331 Lady Hammond Road Suite 100

Halifax, Nova Scotia, B3K 2S2

Canada

Products

1. Pulmonary function analysis system, adult

Product Type

Single Device Product

Effective date

15/02/2014

GMDN

35282 Pulmonary function analysis system, adult

Intended purpose

To monitor lung function through the measurement of airway resistance, reactance and other lung function

parameters. The device assists physicians in the diagnosis, treatment selection and evaluation of efficacy

by providing accurate, reproducible and high quality lung-function data

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 04:59:15 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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