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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name brain injury adjunctive interpretive electroencephalograph assessment aid
510(k) Number K183241
Device Name BrainScope TBI (Model: Ahead 400)
Applicant
BrainScope Company Inc.
4350 East West Hwy, Ste 1050
Bethesda,  MD  20814
Applicant Contact Michael E Singer
Correspondent
BrainScope Company Inc.
4350 East West Hwy, Ste 1050
Bethesda,  MD  20814
Correspondent Contact Michael E Singer
Regulation Number882.1450
Classification Product Code
PIW  
Subsequent Product Codes
OLU   PKQ  
Date Received11/21/2018
Decision Date 02/19/2019
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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