Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
ResApp Health Ltd - Respiratory sound analysis software
ARTG entry for
Medical Device Included Class IIa
ResApp Health Ltd
Level 8 127 Creek Street,Brisbane, QLD, 4000
ARTG Start Date
Medical Device Class IIa
- 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
Single Device Product
64033 Respiratory sound analysis software
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.
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Produced at 02.11.2019 at 03:13:37 AEDT
This is not an ARTG Certificate document.
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