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510(k) K251936

Ceribell Delirium Monitor System by Ceribell, Inc. — Product Code NCG

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."

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Other clearances for product code NCG

  • K222680 — DeltaScan Monitor (February 2, 2023)
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