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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name automatic event detection software for full-montage electroencephalograph
510(k) Number K171720
Device Name encevis
Applicant
AIT Austrian Institute of Technology GmbH
Donau-City-Strabe 1
Vienna,  AT 1220
Applicant Contact Tilmann Kluge
Correspondent
VISAMED GmbH
Kastellstr, 8
Karlsruhe,  DE D-76227
Correspondent Contact Arne Briest
Regulation Number882.1400
Classification Product Code
OMB  
Subsequent Product Codes
OLT   OMA  
Date Received06/12/2017
Decision Date 04/19/2018
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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