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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name non-normalizing quantitative electroencephalograph software
510(k) Number K123665
Device Name LIFELINES IEEG
Applicant
KVIKNA EHF
1468 HARWELL AVE
CROFTON,  MD  21114
Applicant Contact YOLANDA SMITH
Correspondent
KVIKNA EHF
1468 HARWELL AVE
CROFTON,  MD  21114
Correspondent Contact YOLANDA SMITH
Regulation Number882.1400
Classification Product Code
OLT  
Date Received11/28/2012
Decision Date 03/25/2013
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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