K260907
- 510(k) number
- K260907
- Device name
- BIS Advance pEEG Module
- Applicant
- Covidien LP MA · US
- Product code
- OLW — Index-Generating Electroencephalograph Software
- Decision date
- 2026-08-13
- Date received
- 2026-03-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K260907.pdf
Official FDA record: K260907
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.