K253767
- 510(k) number
- K253767
- Device name
- UB ERP System
- Applicant
- Universal Brain CA · US
- Product code
- OLT — Non-Normalizing Quantitative Electroencephalograph S
- Decision date
- 2026-06-30
- Date received
- 2025-11-25
- 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: K253767.pdf
Official FDA record: K253767
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.