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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 K202334
Device Name Neuronaute
Applicant
Bioserenity Sas
Icm-Ipeps, 47 Blvd. De L'Hopital
Paris,  FR 75013
Applicant Contact Julien Dupont
Correspondent
Bioserenity Sas
Icm-Ipeps, 47 Blvd. De L'Hopital
Paris,  FR 75013
Correspondent Contact Julien Dupont
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Code
GXY  
Date Received08/17/2020
Decision Date 12/10/2020
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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