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Neuroamp EEG Amplifier

by Neurocorp, Ltd.

510(k) K974495

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK974495 Date26 Feb 1998ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GWQ
Device Class
Class II
Regulation
21 CFR Part 882.1400
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Neuroamp EEG Amplifier is an accessory device of integrated systems used for the recording of brain bio-electrical activity. It is intended for the amplification of brain bioelectrical signals recorded from scalp-applied electrodes.

It is supplied as a reusable device and has received FDA 510(k) clearance under K974495. The device is classified as a Class II medical device with product code GWQ and regulation number 882.1400.

Questions

AI-generated answers, 6 Oct 2026

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

  • What is the Neuroamp EEG Amplifier used for?

    The Neuroamp EEG Amplifier is intended for the amplification of brain bioelectrical signals recorded from scalp-applied electrodes, serving as an accessory device in integrated systems for recording brain bio-electrical activity.

  • Is the Neuroamp EEG Amplifier reusable or single-use?

    The Neuroamp EEG Amplifier is supplied as a reusable device, meaning it can be cleaned and used multiple times according to the manufacturer's instructions for use and reprocessing guidelines.

  • What regulatory clearance does the Neuroamp EEG Amplifier have?

    The Neuroamp EEG Amplifier has received FDA 510(k) clearance under submission K974495, is classified as a Class II medical device with product code GWQ, and falls under regulation number 882.1400.