Evo sEEG System— 510(k) K211367

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..

Clearance details

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

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