NeuroNav System, NeuroSmart System— 510(k) K172042

Substantially Equivalent

Alpha Omega Engineering , Ltd.

FDA 510(k) clearance K172042 for NeuroNav System, NeuroSmart System, Substantially Equivalent on 2018-02-27. Applicant: Alpha Omega Engineering , Ltd..

Clearance details

Applicant: Alpha Omega Engineering , Ltd.
Product code: Code GZL
Advisory panel: Neurology
Date received: 2017-07-06
Decision date: 2018-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nazareth, IL

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