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

resapp health ltd - 64033 - respiratory sound analysis software - the resappdx-eu v2 is a mobile software application indicated for use as an aid in the diagnosis of a set of respiratory diseases in patients aged 29 days or older by a clinician.

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

resapp health ltd - 62276 - cough long-term ambulatory recording system - the intended use of the resapp cough counter application is a mobile medical device application (?app?) intended to record the number of identified lung/cough sounds events in a patient aged 29 days and older over a period of time for the management of respiratory disease. the device stores the time and date of each lung/cough event for review by a healthcare provider (hcp). the cough counter is for use by a patient at home or in-clinic to identify and count the number of coughs identified over of time to be review by a healthcare provider on a mobile app or log file.

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

resapp health ltd - 42238 - polysomnography device application software - the intended use of the sleepcheck application (?app?) is as a screening device used to analyse an adult?s breathing and snore sounds during sleep to assess their risk of obstructive sleep apnoea (osa).the app is designed to be used by laypersons over the age of 18 for their own use in a non-clinical environment such as their own home. this test does not provide a diagnosis and is not intended as a substitute for a sleep study.

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

resapp health ltd - 62276 - cough long-term ambulatory recording system - the wearable device is intended to be used to record coughs when monitoring a patient. the wearable itself does not diagnose respiratory disease.

Singapore - English - HSA (Health Sciences Authority)

ynl 360 pte ltd - ear, nose & throat - resappdx is a software application intended to in aid in the diagnosis of common respiratory illnesses in children (aged 29 days or older), adolescents and adults, under the direction of a healthcare provider (either directly or via telehealth). the device provides a qualitative output based on cough analysis to the healthcare provider resappdx has an in-clinic and a remote telehealth mode; both have the same intended use. the only difference is that the clinical supervision for resappdx when in remote mode is performed via a telehealth platform.

Ireland - English - HPRA (Health Products Regulatory Authority)

brillpharma (ireland) limited - furosemide - tablet - 20 milligram(s) - sulfonamides, plain; furosemide

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

fisher & paykel healthcare pty ltd - 60965 - respiratory gas heating wire, infant - intended to be integrated within a ventilator breathing circuit and used in conjunction with a heated respiratory humidifier to maintain the temperature of inspiratory gases during ventilation.

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

fisher & paykel healthcare pty ltd - 60966 - respiratory gas heating wire, adult - intended to be integrated within a ventilator breathing circuit and used in conjunction with a heated respiratory humidifier to maintain the temperature of inspiratory gases during ventilation.

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

fisher & paykel healthcare pty ltd - 61028 - respiratory gas heating wire electrical connection cable - the electrical adaptor is intended to provide an electrical connection between a resiparory gas heating wire and a respiratory humidifier during ventilation of a patient.

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

fisher & paykel healthcare pty ltd - 61028 - respiratory gas heating wire electrical connection cable - the electrical adaptor is intended to provide an electrical connection between a resiparory gas heating wire and a respiratory humidifier during ventilation of a patient.