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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 K223504
Device Name Ceribell Status Epilepticus Monitor
Ceribell, Inc.
360 N Pastoria Ave
Sunnyvale,  CA  94085
Applicant Contact Raymond Woo
Ceribell, Inc.
360 N Pastoria Ave
Sunnyvale,  CA  94085
Correspondent Contact Raymond Woo
Regulation Number882.1400
Classification Product Code
Date Received11/22/2022
Decision Date 05/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No