Cleared Traditional

NeuroNav System, NeuroSmart System

K172042 · Alpha Omega Engineering , Ltd. · Neurology
Feb 2018
Decision
236d
Days
Class 2
Risk

About This 510(k) Submission

K172042 is an FDA 510(k) clearance for the NeuroNav System, NeuroSmart 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 February 27, 2018, 236 days after receiving the submission on July 6, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1330.

Submission Details

510(k) Number K172042 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2017
Decision Date February 27, 2018
Days to Decision 236 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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