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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 K171184
Device Name Persyst Mobile App
Applicant
Persyst Development Corporation
420 Stevens Avenue
Suite 210
Solana Beach,  CA  92075
Applicant Contact Dari Darabbeigi
Correspondent
Persyst Development Corporation
420 Stevens Avenue
Suite 210
Solana Beach,  CA  92075
Correspondent Contact Dari Darabbeigi
Regulation Number882.1400
Classification Product Code
OMB  
Subsequent Product Codes
OLT   OMA  
Date Received04/24/2017
Decision Date 09/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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