K252565
- 510(k) number
- K252565
- Device name
- PreOp v3
- Applicant
- Clouds of Care BE
- Product code
- OLX — Source Localization Software For Electroencephalogra
- Decision date
- 2026-02-13
- Date received
- 2025-08-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K252565.pdf
Official FDA record: K252565
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.