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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 Boulevard de l'Hopital
Paris,  FR 75013
Applicant Contact Julien Dupont
Correspondent
Bioserenity SAS
ICM-iPEPS, 47 Boulevard 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
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