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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automatic Event Detection Software For Full-Montage Electroencephalograph
510(k) Number K241589
Device Name Ceribell Seizure Detection Software
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
OMB  
Date Received06/03/2024
Decision Date 04/09/2025
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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