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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name source localization software for electroencephalograph or magnetoencephalograph
510(k) Number K172858
Device Name PreOp
Applicant
Epilog
Vlasgaardstraat 52
Ghent,  BE 9000
Applicant Contact Gregor Strobbe
Correspondent
Qserve Group US Inc.
5600 Wisconsin Avenue
Chevy Chase,  MD  20815
Correspondent Contact Patsy Trisler
Regulation Number882.1400
Classification Product Code
OLX  
Date Received09/20/2017
Decision Date 01/08/2018
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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