Evo® sEEG System— 510(k) K222404

Substantially Equivalent

Neuroone Medical Technologies Corp.

FDA 510(k) clearance K222404 for Evo® sEEG System, Substantially Equivalent on 2022-10-20. Applicant: Neuroone Medical Technologies Corp..

Clearance details

Applicant: Neuroone Medical Technologies Corp.
Product code: Code GZL
Advisory panel: Neurology
Date received: 2022-08-09
Decision date: 2022-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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