Respiratory sound analysis software

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

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

Public Summary

Summary for ARTG Entry:


ResApp Health Ltd - Respiratory sound analysis software

ARTG entry for

Medical Device Included Class IIa


ResApp Health Ltd

Postal Address

Level 8 127 Creek Street,Brisbane, QLD, 4000


ARTG Start Date


Product category

Medical Device Class IIa



Approval area

Medical Devices


- 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.




ResApp Health Ltd

Level 8 127 Creek Street

Brisbane, QLD, 4000



1. Respiratory sound analysis software

Product Type

Single Device Product

Effective date



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

Public Summary

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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.

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