K233618
- 510(k) number
- K233618
- Device name
- Oxevision Sleep Device
- Applicant
- Oxehealth Limited GB
- Product code
- LEL — Device, Sleep Assessment
- Decision date
- 2024-04-03
- Date received
- 2023-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K233618.pdf
Official FDA record: K233618
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.