Respiratory sound analysis software

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

Buy It Now

Available from:
ResApp Health Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
324285

Public Summary

Summary for ARTG Entry:

324285

ResApp Health Ltd - Respiratory sound analysis software

ARTG entry for

Medical Device Included Class IIa

Sponsor

ResApp Health Ltd

Postal Address

Level 8 127 Creek Street,Brisbane, QLD, 4000

Australia

ARTG Start Date

1/10/2019

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

ResApp Health Ltd

Level 8 127 Creek Street

Brisbane, QLD, 4000

Australia

Products

1. Respiratory sound analysis software

Product Type

Single Device Product

Effective date

1/10/2019

GMDN

64033 Respiratory sound analysis software

Intended purpose

The ResAppDx-EU application is a mobile software application indicated for use as an aid in the diagnosis

of a set of respiratory diseases by a clinician. The set of respiratory diseases detected are: lower

respiratory tract disease, asthma/reactive airway disease, croup, pneumonia and bronchiolitis. The app is

to be used on infants and children aged 29 days up to 12 years old who produce involuntary/spontaneous

coughs or are able to cooperate in providing voluntary cough sounds. The device provides a qualitative

output based on cough sound analysis to the clinician. The ResAppDx-EU application is to be used by the

clinician along with a standard assessment of the patient to aid with the diagnosis.

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 03:13:37 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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