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Mitsar-EEG

by Mitsar Co., Ltd. Russia 510(k)

510(k) K143233

Product code GWQ

Overview

The Mitsar-EEG is a full‑montage standard electroencephalograph designed for neurophysiology and neurology applications. It records multi‑channel EEG signals and supports video EEG monitoring, spectral analysis, and evoked‑potential recordings. The system can acquire up to 21 channels of quantitative EEG plus additional channels for ECG, EOG, EMG, and respiration, and may include a Bluetooth option for wireless data transfer.

The device is marketed by Mitsar Co., Ltd. and is classified as a Class II medical device with FDA 510(k) clearance (traditional, substantially equivalent) under product code GWQ. It is identified by the FDA registration number K143233 and regulation number 882.1400. The system is supplied as a complete EEG platform and is intended for use in clinical and research settings under the applicable regulatory authorisations.

Summary written by AI from registry data, 23 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK143233 Date13 Aug 2015ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
GWQ
Device Class
Class II
Regulation
21 CFR Part 882.1400
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the Mitsar-EEG used for?

    The Mitsar-EEG is a full-montage standard electroencephalograph designed for neurophysiology and neurology applications. It records multi-channel EEG signals and supports video EEG monitoring, spectral analysis, and evoked-potential recordings.

  • How many channels does the Mitsar-EEG system support?

    The Mitsar-EEG system can acquire up to 21 channels of quantitative EEG plus additional channels for ECG, EOG, EMG, and respiration. It may also include a Bluetooth option for wireless data transfer.

  • What is the regulatory classification of the Mitsar-EEG?

    The Mitsar-EEG is classified as a Class II medical device with FDA 510(k) clearance under product code GWQ. It has FDA registration number K143233 and is regulated under number 882.1400.

  • In what settings is the Mitsar-EEG intended to be used?

    The Mitsar-EEG system is supplied as a complete EEG platform and is intended for use in both clinical and research settings under the applicable regulatory authorizations.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K143233 24 fields · synced 22 Oct 2026