K260880
- 510(k) number
- K260880
- Device name
- SedLine Sedation Monitor
- Applicant
- Masimo Corporation CA · US
- Product code
- OLW — Index-Generating Electroencephalograph Software
- Decision date
- 2026-07-10
- Date received
- 2026-03-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K260880.pdf
Official FDA record: K260880
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.