FDA Product Code QZW: Over-the-counter Device To Assess Risk Of Sleep Apnea
An Over-the-counter Device To Assess Risk Of Sleep Apnea Is Intended To Provide A Notification Of The Risk Of Sleep Apnea In Users Who Have Not Been Previously Diagnosed With Sleep Apnea. This Device Uses Software Algorithms To Analyze Input Sensor Signals And Provide A Risk Assessment For Sleep Apnea. It Is Not Intended To Provide A Standalone Diagnosis, Replace Traditional Methods Of Diagnosis (e.g., Polysomnography), Assist Clinicians In Diagnosing Sleep Disorders, Or Be Used As An Apnea Monitor.
Leading manufacturers include Samsung Electronics Co., Ltd..
List of Over-the-counter Device To Assess Risk Of Sleep Apnea devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Over-the-counter Device To Assess Risk Of Sleep Apnea devices (product code QZW). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Anesthesiology FDA review panel. Browse all Anesthesiology devices →