Device Dossier
Sleep assessment device
Device Dossier for Sleep assessment device (Sleep assessment device, Class IIa, sponsor Philips Electronics). ARTG record, intended purpose, GMDN…
- GMDN category: Sleep assessment device
Intended purpose
Device designed to assess nasal airflow during sleep. Apnea events are counted based on reduction of airflow. This device is intended for use as a screening device to determine the need for clinical evaluation and diagnosis of sleep apnea based on the patient?s score.