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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software
510(k) Number K220254
Device Name Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
Applicant
Neurosoft , Ltd.
5, Voronin St.
Ivanovo,  RU 153032
Applicant Contact Michael Durdin
Correspondent
Corticare, Inc.
5950 La Pl. Ct., Suite 160
Carlsbad,  CA  92008
Correspondent Contact Vicki Chester
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Codes
GWQ   OLV  
Date Received01/31/2022
Decision Date 11/30/2022
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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