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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 K150688
Device Name IdentEvent
Applicant
OPTIMA NEUROSCIENCE, INC.
11930 Research Circle
Alachua,  FL  32615
Applicant Contact Ryan T. Kern
Correspondent
OPTIMA NEUROSCIENCE, INC.
11930 Research Circle
Alachua,  FL  32615
Correspondent Contact Ryan T. Kern
Regulation Number882.1400
Classification Product Code
OMB  
Subsequent Product Code
OLT  
Date Received03/17/2015
Decision Date 11/05/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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