K252981
- 510(k) number
- K252981
- Device name
- EmbraceMini
- Applicant
- Empatica S.r.l. IT
- Product code
- LEL — Device, Sleep Assessment
- Decision date
- 2025-12-22
- Date received
- 2025-09-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K252981.pdf
Official FDA record: K252981
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.