K250851
- 510(k) number
- K250851
- Device name
- Hypnos (369054-200)
- Applicant
- Cadwell Industries, Inc. WA · US
- Product code
- OLZ — Automatic Event Detection Software For Polysomnograp
- Decision date
- 2025-12-14
- Date received
- 2025-03-21
- 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: K250851.pdf
Official FDA record: K250851
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.