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Neon EEG

by Incereb Ltd

510(k) K151576

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K151576↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK151576 Date29 Sep 2015ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
GXY
FDA applicant
Incereb, Ltd.
Device Class
Class II
Regulation
21 CFR Part 882.1320
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Neon EEG is a neonatal electroencephalography (EEG) electrode system designed for non-invasive monitoring of brain activity in infants. It features pre-pasted, single-use electrode arrays with standardized placements to ensure consistent and rapid electrode application, reducing the complexity of neonatal EEG procedures.

The Neon EEG system includes reusable interface cables compatible with EEG machines and aEEG monitors equipped with either 1.5mm touch-proof or D-type connectors. Supplied in two sizes—six or ten recording electrodes plus Cz reference and ground—the system is intended for single-use applications in neonatal care settings. Authorized under FDA 510(k) and MDR, it adheres to regulatory standards for medical device safety and performance.

Other devices from Incereb Ltd

  • Neon10

    Class I

  • Neon12

    Class I

  • Neon8

    Class I

  • Neon12

    Class I

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of neonatal EEG monitoring systems can the Neon EEG system be used with, and how does this affect compatibility?

    The Neon EEG system is designed to work with EEG machines and aEEG (amplitude-integrated EEG) monitors that have either 1.5mm touch-proof or D-type connectors. This flexibility ensures broad compatibility with standard neonatal monitoring equipment, making it adaptable for use in various clinical settings where brain activity in infants needs to be tracked.

  • Are the Neon EEG electrodes reusable, or are they intended for single-use only? How does this impact clinical workflow?

    The Neon EEG electrodes are single-use only, which eliminates the need for cleaning, sterilization, or reprocessing between patients. This reduces infection risk, simplifies workflow, and ensures consistent performance for each procedure, as the pre-pasted design also speeds up application and reduces setup time.

  • What electrode configurations are available, and how do they differ in terms of brain activity coverage?

    The Neon EEG system offers two electrode configurations: a six-electrode array and a ten-electrode array, both including a Cz reference and ground. The ten-electrode version provides expanded coverage for more detailed brain activity monitoring compared to the six-electrode setup, allowing clinicians to choose based on the level of detail required for their patient’s assessment.

  • How does the pre-pasted design of the Neon EEG electrodes benefit neonatal patients and healthcare providers?

    The pre-pasted electrodes are designed for rapid and standardized application, reducing the time and effort required to prepare for an EEG procedure. This is particularly advantageous in neonatal care, where quick, reliable monitoring is critical, and minimizing patient discomfort or movement during setup is important. The consistent placement also improves data accuracy and comparability across different assessments.