1 device · 1 company · 2024
Product code LEL: Device, Sleep Assessment
1 device under product code LEL, 2024, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Device, Sleep Assessment. 21 CFR 882.5050, Class II. MAUDE held 13 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 |
|---|---|---|---|---|
| Oxevision Sleep DeviceK233618 · 510(k) | Oxehealth Limited | Neurology | database entry |
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