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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 K223644
Device Name Neuronaute with IceCap 2 & IceCap 2 Small
Applicant
Bioserenity
47 Blvd. De L Hopital Icm-Ipeps -
Hopital Pitie Salpetriere - Cs 21414
Paris,  FR 75013
Applicant Contact Madubuike Okafor
Correspondent
Bioserenity
47 Blvd. De L Hopital Icm-Ipeps -
Hopital Pitie Salpetriere - Cs 21414
Paris,  FR 75013
Correspondent Contact Madubuike Okafor
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Code
GXY  
Date Received12/06/2022
Decision Date 01/12/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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