Over-the-counter Device To Assess Risk Of Sleep Apnea — FDA 510(k) Devices
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.
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 →