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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 K182181
Device Name Persyst 14 EEG Review and Analysis Software
Applicant
Persyst Development Corporation
420 Stevens Ave., Suite 210
Solana Beach,  CA  92075
Applicant Contact Dari Darabbeigi
Correspondent
Persyst Development Corporation
420 Stevens Ave., Suite 210
Solana Beach,  CA  92075
Correspondent Contact Dari Darabbeigi
Regulation Number882.1400
Classification Product Code
OMB  
Subsequent Product Codes
OLT   OMA  
Date Received08/13/2018
Decision Date 11/29/2018
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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