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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name reduced- montage standard electroencephalograph
510(k) Number K223628
Device Name NEBA® Compact EEG2R Mobile Headset
Applicant
Neba Health, LLC
2052 Gordon Highway, Ste B.
Augusta,  GA  30909
Applicant Contact Howard Merry
Correspondent
Neba Health, LLC
2052 Gordon Highway, Ste B.
Augusta,  GA  30909
Correspondent Contact Howard Merry
Regulation Number882.1400
Classification Product Code
OMC  
Subsequent Product Code
GXY  
Date Received12/05/2022
Decision Date 03/02/2023
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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