NeuroOne Cortical Electrode— 510(k) K192764

Substantially Equivalent

Neuroone, Inc.

FDA 510(k) clearance K192764 for NeuroOne Cortical Electrode, Substantially Equivalent on 2019-11-26. Applicant: Neuroone, Inc..

Clearance details

Applicant: Neuroone, Inc.
Product code: Code GYC
Advisory panel: Neurology
Date received: 2019-09-30
Decision date: 2019-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

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