Cleared Special

Neuro Omega System; NeuroSmart System

K250601 · Alpha Omega Engineering , Ltd. · Neurology
Mar 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K250601 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 March 30, 2025, 30 days after receiving the submission on February 28, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1330.

Submission Details

510(k) Number K250601 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2025
Decision Date March 30, 2025
Days to Decision 30 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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