K254213
- 510(k) number
- K254213
- Device name
- Pascall Sensor Unit (PSU1)
- Applicant
- Pascall Systems, Inc. MA · US
- Product code
- OLT — Non-Normalizing Quantitative Electroencephalograph S
- Decision date
- 2026-08-19
- Date received
- 2025-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K254213.pdf
Official FDA record: K254213
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.