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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 K210805
Device Name Ceribell Instant EEG Headband
Applicant
Ceribell, Inc.
2483 Old Middlefield Way, Suite 120
Mountain View,  CA  94043
Applicant Contact Raymond Woo
Correspondent
Ceribell, Inc.
2483 Old Middlefield Way, Suite 120
Mountain View,  CA  94043
Correspondent Contact Raymond Woo
Regulation Number882.1320
Classification Product Code
GXY  
Subsequent Product Code
GWQ  
Date Received03/17/2021
Decision Date 08/30/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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