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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 K193159
Device Name NeuroAmp II, NeuroAmp II.5s
Applicant
Corscience GmbH & Co. KG
Hartmannstrasse 65
Erlangen,  DE 91052
Applicant Contact Stefan Bolleininger
Correspondent
Corscience GmbH & Co. KG
Hartmannstrasse 65
Erlangen,  DE 91052
Correspondent Contact Stefan Bolleininger
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Codes
GWE   GWJ   HCC   OLV  
Date Received11/15/2019
Decision Date 12/30/2020
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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