Cleared Traditional

Neuro Omega System

K171581 · Alpha Omega Engineering , Ltd. · Neurology
Dec 2017
Decision
205d
Days
Class 2
Risk

About This 510(k) Submission

K171581 is an FDA 510(k) clearance for the Neuro Omega System, a Electrode, Depth (Class II — Special Controls, product code GZL), submitted by Alpha Omega Engineering , Ltd. (Nazareth, IL). The FDA issued a Cleared decision on December 22, 2017, 205 days after receiving the submission on May 31, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1330.

Submission Details

510(k) Number K171581 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2017
Decision Date December 22, 2017
Days to Decision 205 days
Submission Type Traditional
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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