Cognision EEG/EP System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K141316

Identifiers

510(k) Number: K141316 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)

The Cognision EEG/EP System is a non-normalizing quantitative electroencephalograph software device. It is designed for the acquisition, display, analysis, storage, reporting, and management of electroencephalograph and auditory evoked potentials information to evaluate cognitive function.

This system is intended for use by qualified clinical professionals in private practice offices or clinical settings. It has received FDA 510(k) clearance under the product code OLT and regulation number 882.1400.

Frequently asked questions

What is the primary function of the Cognision EEG/EP System?

The system is designed for the acquisition, display, analysis, storage, reporting, and management of electroencephalograph and auditory evoked potentials information to help qualified clinical professionals evaluate cognitive function.

Who is the intended user for this device?

This system is intended for use by qualified clinical professionals. It is designed to be operated within private practice offices or other professional clinical settings.

What is the regulatory status of the Cognision EEG/EP System?

The device has received FDA 510(k) clearance. It is classified under regulation number 882.1400 and is associated with product code OLT.

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: COGNISION - Neuronetrix - PDF Catalogs | Technical Documentation, COGNISION EEG/EP SYSTEM (K141316) — FDA 510(k) | Innolitics, For Physicians | Cognision

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K141316	Class II	Active

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Manufacturer

Manufacturer: Neuronetrix Solutions

Sources (1)

FDA 510(k) K141316 24 fields · synced Sep 25, 2026