K253390
- 510(k) number
- K253390
- Device name
- SOMNUM (SOMNUM)
- Applicant
- Honeynaps Co., Ltd. KR
- Product code
- OLZ — Automatic Event Detection Software For Polysomnograp
- Decision date
- 2026-06-27
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253390.pdf
Official FDA record: K253390
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.