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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 K132306
Device Name PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE
Applicant
Persyst Development Corp.
12625 High Bluff Dr., Suite 213
San Diego,  CA  92130
Applicant Contact DARI DARABBEIGI
Correspondent
Persyst Development Corp.
12625 High Bluff Dr., Suite 213
San Diego,  CA  92130
Correspondent Contact DARI DARABBEIGI
Regulation Number882.1400
Classification Product Code
OMB  
Subsequent Product Codes
OLT   OMA  
Date Received07/24/2013
Decision Date 11/21/2013
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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