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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 K254033
Device Name Ceribell Instant EEG Headset
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 Angela Lynch
Regulation Number882.1320
Classification Product Code
GXY  
Date Received12/16/2025
Decision Date 02/09/2026
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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