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Galileo NT

FDA 510(k)

Class II (US FDA 510(k))

510(k) K142064

by EB Neuro S.p.A.

Identifiers

510(k) Number
K142064 FDA 510(k)
FDA Product Code
OLT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1400 FDA 510(k)
Regulation Number
882.1400 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Galileo NT is a software-only device running on Windows PCs that manages neurodiagnostic exams including EEG, EMG, EP, and PSG. It interfaces with FDA-cleared EBNeuro amplifier platforms to acquire physiological signals and provides modules for patient acceptance, test execution, data display, measurement, trending, and archiving.

The device is supplied as software and is intended for use in clinical neurophysiology settings. It is regulated under FDA 510(k) clearance K142064, classified as a Class II device with product code OLT and regulation number 882.1400, and is substantially equivalent to a predicate device.

Frequently asked questions

What is Galileo NT used for?

Galileo NT manages neurodiagnostic exams including EEG, EMG, EP, and PSG by providing modules for patient acceptance, test execution, data display, measurement, trending, and archiving when interfaced with compatible EBNeuro amplifier platforms.

How is Galileo NT supplied and what does it require to operate?

Galileo NT is supplied as software-only and runs on Windows PCs; it requires connection to FDA-cleared EBNeuro amplifier platforms to acquire physiological signals for neurodiagnostic testing.

Is Galileo NT a single-use or reusable device?

As a software-only device, Galileo NT is designed for repeated use in clinical settings; it does not have physical components that are consumed or degraded during operation, allowing for ongoing reuse under appropriate software management.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EB Neuro Products | EEG, EMG & EP Systems | Brain Ultimate, Galileo NT Line - EEG.NET - EBNeuro, GALILEO NT (K142064) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
EB Neuro S.p.A.

Sources (1)

  • FDA 510(k) K142064 24 fields · synced Sep 22, 2026