Neuro Omega System, NeuroSmart System— 510(k) K220553

Substantially Equivalent

Alpha Omega Engineering , Ltd.

FDA 510(k) clearance K220553 for Neuro Omega System, NeuroSmart System, Substantially Equivalent on 2022-09-16. Applicant: Alpha Omega Engineering , Ltd..

Clearance details

Applicant: Alpha Omega Engineering , Ltd.
Product code: Code GZL
Advisory panel: Neurology
Date received: 2022-02-28
Decision date: 2022-09-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Nof Hagalil (Nazareth Illit), IL

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