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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K143233
FOIA Releasable 510(k) K143233
Device Name Mitsar-EEG
Applicant
Mitsar Co., Ltd.
Novorossiyskaya St. 21-2
St. Petersburg,  RU 194021
Applicant Contact Semchenkov Ales
Correspondent
Nova Tech Eeg
8503 E. Keats Ave.
Mesa,  AZ  85209
Correspondent Contact Leslie Sherlin
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received11/10/2014
Decision Date 08/13/2015
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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