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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reduced- Montage Standard Electroencephalograph
510(k) Number K261101
Device Name Ceribell Monitor
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 Number882.1400
Classification Product Code
OMC  
Subsequent Product Code
GWQ  
Date Received04/02/2026
Decision Date 06/30/2026
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		 No
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