Device Dossier

Pulmonary function testing filter/mouthpiece

Device Dossier for Pulmonary function testing filter/mouthpiece (Pulmonary function testing filter/mouthpiece, Class IIa, sponsor Sonic Equipment). ARTG…

Intended purpose

A single use sensor (mouthpiece) that fits the Fim Medical Spirolyser. This fits into the Spirolyser housing allow the patient to blow though it and recordings made on the Spirolyser software. It is packaged in such a way to allow a no touch technique to be used in it's insertion and disposal. The device is invasive via the oral cavity only.

TGA Public Summary