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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K260363
Device Name Ceribell Brain Monitor Headband
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 Number882.1320
Classification Product Code
GXY  
Date Received02/04/2026
Decision Date 04/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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