K230693
- 510(k) number
- K230693
- Device name
- BIS Advance Monitoring System
- Applicant
- Covidien, LLC CO · US
- Product code
- OLW — Index-Generating Electroencephalograph Software
- Decision date
- 2024-02-26
- Date received
- 2023-03-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K230693.pdf
Official FDA record: K230693
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.