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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 str. 21-2
St. Petersburg,  RU 194021
Applicant Contact Semchenkov Ales
Correspondent
Nova Tech EEG
8503 E. Keats Avenue
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
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