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Entropy Module E-ENTROPY-01

by Ge Healthcare Filand OY

510(k) K150298

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

No date given

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) K150298↗

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 NumberK150298 Date12 Nov 2015ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive
European UnionCE/MDD 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  • Withdrawn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, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
OLW
Device class
Class II
Regulation
21 CFR Part 882.1400
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 Entropy Module E-ENTROPY-01 is an index-generating electroencephalograph software module designed for neurological assessment. It processes electroencephalogram (EEG) signals to generate entropy metrics, which quantify brain activity patterns and aid in the evaluation of neurological function, particularly in critical care settings.

This device is supplied as a reusable module integrated with EEG systems and is intended for use in clinical environments. It requires compatibility with specific EEG platforms and is regulated under FDA 510(k) clearance, MDD, and MDR compliance. The module operates within Class II medical device classification and is authorized for use in neurology applications, adhering to strict regulatory standards for diagnostic accuracy and safety.