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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 K232052
Device Name Ceribell Instant EEG Headband
Applicant
Ceribell, Inc.
360 North Pastoria Avenue
Sunnyvale,  CA  94085
Applicant Contact Raymond Woo
Correspondent
Ceribell, Inc.
360 North Pastoria Avenue
Sunnyvale,  CA  94085
Correspondent Contact Raymond Woo
Regulation Number882.1320
Classification Product Code
GXY  
Subsequent Product Code
GWQ  
Date Received07/10/2023
Decision Date 08/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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