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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name normalizing quantitative electroencephalograph software
510(k) Number K191432
Device Name cortiQ PRO
Applicant
g.tec medical engineering GmbH
Sierningerstrasse 14
schiedlberg,  AT 4521
Applicant Contact christoph guger
Correspondent
g.tec medical engineering GmbH
Sierningerstrasse 14
schiedlberg,  AT 4521
Correspondent Contact christoph guger
Regulation Number882.1400
Classification Product Code
OLU  
Subsequent Product Codes
GWL   OLT  
Date Received05/29/2019
Decision Date 01/24/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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