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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
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