Cleared Special

Neuro Omega System, NeuroSmart System

K220553 · Alpha Omega Engineering , Ltd. · Neurology
Sep 2022
Decision
200d
Days
Class 2
Risk

About This 510(k) Submission

K220553 is an FDA 510(k) clearance for the Neuro Omega System, NeuroSmart System, a Electrode, Depth (Class II — Special Controls, product code GZL), submitted by Alpha Omega Engineering , Ltd. (Nof Hagalil (Nazareth Illit), IL). The FDA issued a Cleared decision on September 16, 2022, 200 days after receiving the submission on February 28, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1330.

Submission Details

510(k) Number K220553 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2022
Decision Date September 16, 2022
Days to Decision 200 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GZL — Electrode, Depth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1330

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