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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 K240993
Device Name encevis (2.1)
Applicant
AIT Austrian Institute of Technology GmbH
Giefinggasse 4
Vienna,  AT 1210
Applicant Contact Tilmann Kluge
Correspondent
AIT Austrian Institute of Technology GmbH
Giefinggasse 4
Vienna,  AT 1210
Correspondent Contact Tilmann Kluge
Regulation Number882.1400
Classification Product Code
OMB  
Subsequent Product Codes
OLT   OMA  
Date Received04/11/2024
Decision Date 09/27/2024
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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