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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 K222002
Device Name Persyst 15 EEG Review and Analysis Software
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   OLX   OMA  
Date Received07/07/2022
Decision Date 12/30/2022
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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