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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
Predetermined Change
Control Plan Authorized		 No
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