Evo sEEG System— 510(k) K211367

Name: FDA 510(k) clearance K211367
Creator: U.S. Food and Drug Administration
Published: 2021-09-01

Substantially Equivalent

Neuroone Medical Technologies Corp.

FDA 510(k) clearance K211367 for Evo sEEG System, Substantially Equivalent on 2021-09-01. Applicant: Neuroone Medical Technologies Corp.. Device class: 2.

Clearance details

Applicant: Neuroone Medical Technologies Corp.
Product code: Code GZL
Device class: Class 2
Regulation: 21 CFR 882.1330
Advisory panel: Neurology
Date received: 2021-05-04
Decision date: 2021-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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