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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 K092039
Device Name IDENTEVENT, VERSION 1.0G
Applicant
Optima Neuroscience, Inc.
12337 NW 9th Lane
Newberry,  FL  32669
Applicant Contact PAULA WILKERSON
Correspondent
Optima Neuroscience, Inc.
12337 NW 9th Lane
Newberry,  FL  32669
Correspondent Contact PAULA WILKERSON
Regulation Number882.1400
Classification Product Code
OMB  
Subsequent Product Code
OLT  
Date Received07/06/2009
Decision Date 10/16/2009
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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