2 devices · 2 companies · 2024
Product code QZW: Over-The-Counter Device To Assess Risk Of Sleep Apnea
2 devices under product code QZW, 2024, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
Over-The-Counter Device To Assess Risk Of Sleep Apnea. 21 CFR 868.2378, Class II. 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. MAUDE held 2 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Sleep Apnea Notification FeatureK240929 · 510(k) | Apple Inc. | Anesthesiology | database entry | |
| Sleep Apnea FeatureDEN230041 · De Novo | Samsung Electronics Co., Ltd | Anesthesiology | database entry |
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