Over-The-Counter Device To Assess Risk Of Sleep Apnea
QZW · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.2378
Classification
FDA Product Code
QZW
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 868.2378
Review panel
AN
Medical specialty
Anesthesiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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.