Sleep Apnea Feature is an AI-enabled medical device from Samsung Electronics Co., Ltd, listed by FDA (De Novo, DEN230041) with a decision date of 2024-02-06. Review panel: Anesthesiology.
| FDA submission number | DEN230041 |
|---|---|
| Pathway | De Novo |
| Company | Samsung Electronics Co., Ltd |
| Review panel (specialty) | Anesthesiology |
| FDA decision date | 2024-02-06 |
| Decision | Unknown |
| Product code | QZW |
| Classification | Over-The-Counter Device To Assess Risk Of Sleep Apnea |
| Device class | 2 |
| Regulation number | 868.2378 |
| Review time (calendar days) | 251 |
| Applicant country | KR |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.