Cleared Traditional

NEURO OMEGA SYSTEM

K123796 · Alpha Omega Engineering , Ltd. · Neurology
Apr 2013
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K123796 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. (Caesarea, IL). The FDA issued a Cleared decision on April 5, 2013, 116 days after receiving the submission on December 10, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1330.

Submission Details

510(k) Number K123796 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2012
Decision Date April 05, 2013
Days to Decision 116 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

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

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