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EEG-5400 Series

FDA 510(k)

Class II (US FDA 510(k))

510(k) K902550

by Nihon Kohden America, Inc.

Identifiers

510(k) Number
K902550 FDA 510(k)
FDA Product Code
GWQ 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 EEG-5400 Series is a Full-Montage Standard Electroencephalograph, a Class II medical device designed for recording electrical activity in the brain. It captures and displays brainwave patterns to aid in the diagnosis and monitoring of neurological conditions, including epilepsy, sleep disorders, and other brain-related abnormalities. The device employs multiple electrodes placed on the scalp to measure voltage fluctuations, providing real-time or continuous EEG data for clinical assessment.

This device is intended for use in clinical settings such as hospitals, neurology clinics, and sleep laboratories. Supplied as a reusable system, it requires proper calibration and maintenance to ensure accurate and reliable performance. The EEG-5400 Series has received FDA 510(k) clearance under the Traditional pathway, with a decision date of March 19, 1991 (K902550). It adheres to regulatory standards outlined in 21 CFR 882.1400 and is classified under product code GWQ, with advisory committee oversight from the Neurology (NE) Panel. Sterility and MRI safety are not specified in the available data.

Frequently asked questions

What is the EEG-5400 Series used for?

The EEG-5400 Series is a Full-Montage Standard Electroencephalograph designed to record and display electrical activity in the brain. It helps clinicians diagnose and monitor neurological conditions such as epilepsy, sleep disorders, and other brain-related abnormalities by capturing voltage fluctuations through multiple scalp electrodes. This real-time or continuous data aids in clinical assessment and treatment planning.

Is the EEG-5400 Series reusable or single-use?

The EEG-5400 Series is supplied as a reusable system. To ensure accurate and reliable performance, it requires proper calibration and maintenance. Reusability is common for electroencephalographs to maintain consistency in clinical settings, but it also necessitates adherence to strict cleaning and sterilization protocols to prevent cross-contamination and maintain device integrity.

What clinical settings is the EEG-5400 Series intended for?

This device is intended for use in clinical environments such as hospitals, neurology clinics, and sleep laboratories. These settings provide the necessary infrastructure for accurate electrode placement, patient monitoring, and data interpretation by trained professionals. The design supports continuous or real-time EEG recording, which is critical for diagnosing and managing neurological conditions.

How is the EEG-5400 Series regulated?

The EEG-5400 Series has received FDA 510(k) clearance under the Traditional pathway, with a decision date of March 19, 1991. It adheres to regulatory standards outlined in 21 CFR 882.1400 and is classified under product code GWQ. The device was reviewed by the Neurology (NE) Panel, ensuring its compliance with safety and performance requirements for electroencephalographic equipment in clinical use.

Are there different models or sizes available in the EEG-5400 Series?

The EEG-5400 Series includes multiple models, as indicated by the extensive list of registration numbers (e.g., 3005550372, 3020223448, etc.). These variations may correspond to different configurations, electrode placements, or software updates tailored for specific clinical needs. While the exact specifications for each model are not detailed here, the series is designed to accommodate a range of neurological assessments, ensuring flexibility for various diagnostic scenarios.

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: EEG-5400 SERIES (K902550) — FDA 510 (k) | Innolitics, Eeg-5400 Series 510 (k) FDA Premarket Notification K902550 NIHON KOHDEN ..., EEG Software - us.nihonkohden.com, Neurology - NIHON KOHDEN GLOBAL

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nihon Kohden America, Inc.

Sources (1)

  • FDA 510(k) K902550 24 fields · synced Oct 1, 2026