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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name full-montage standard electroencephalograph
510(k) Number K170138
Device Name NEURONAUTE
Applicant
BIOSERENITY
47 boulevard de l'Hopital
Paris,  FR 75013
Applicant Contact Quang TRAN
Correspondent
Voisin Consulting Inc. Life Sciences
222 Third Street
Suite 3121
Cambridge,  MA  02142
Correspondent Contact Esin YESILALAN
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Code
GXY  
Date Received01/17/2017
Decision Date 12/26/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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