Mitsar-EEG— 510(k) K143233

Substantially Equivalent

Mitsar Co., Ltd.

FDA 510(k) clearance K143233 for Mitsar-EEG, Substantially Equivalent on 2015-08-13. Applicant: Mitsar Co., Ltd.. Device class: 2.

Clearance details

Applicant: Mitsar Co., Ltd.
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2014-11-10
Decision date: 2015-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Petersburg, RU

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.