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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 K171459
Device Name Ceribell Instant EEG Headband
Applicant
Ceribell, Inc.
2483 Old Middlefield Way
Suite 120
Mountainview,  CA  94043
Applicant Contact Josef Parvizi
Correspondent
Ceribell, Inc.
2483 Old Middlefield Way
Suite 120
Mountainview,  CA  94043
Correspondent Contact Josef Parvizi
Regulation Number882.1320
Classification Product Code
GXY  
Subsequent Product Code
GWQ  
Date Received05/18/2017
Decision Date 08/21/2017
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		 No
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