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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 K181785
Device Name Modified BrainScope One
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 Received07/03/2018
Decision Date 12/19/2018
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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