510(k) K251936
K251936 is an FDA 510(k) premarket notification submitted by Ceribell, Inc. for the device "Ceribell Delirium Monitor System". The FDA issued a decision of Substantially Equivalent on December 8, 2025. The device falls under product code NCG (Neuropsychiatric Interpretative Electroencephalograph Assessment Aid), a Class II device regulated under 21 CFR 882.1440. Ceribell, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 2025
- Date Received
- June 24, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
- Device Class
- Class II
- Regulation Number
- 882.1440
- Review Panel
- NE
- Submission Type
Uses a patient's electroencephalograph (EEG) to provide an interpretation of the patient's neuropsychiatric condition. It is also used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis."