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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplitude-Integrated Electroencephalograph
510(k) Number K192889
Device Name Neo
Applicant
Eemagine Medical Imaging Solutions GmbH
Gubener St. 47
Berlin,  DE D-10243
Applicant Contact Maarten Van De Velde
Correspondent
Steve Hesler
2602 5th Ave.
West Linn,  OR  97068
Correspondent Contact Steve Hesler
Regulation Number882.1400
Classification Product Code
OMA  
Subsequent Product Codes
OMC   ORT  
Date Received10/10/2019
Decision Date 01/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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