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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
510(k) Number K251936
Device Name Ceribell Delirium Monitor System
Applicant
Ceribell, Inc.
360 N. Pastoria Ave.
Sunnyvale,  CA  94085
Applicant Contact Raymond Woo
Correspondent
Ceribell, Inc.
360 N. Pastoria Ave.
Sunnyvale,  CA  94085
Correspondent Contact Raymond Woo
Regulation Number882.1440
Classification Product Code
NCG  
Subsequent Product Codes
GWQ   OMC  
Date Received06/24/2025
Decision Date 12/08/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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