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EEG Neuroamp, Model CS10137

by Corscience GmbH & Co. KG

510(k) K073557

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK073557 Date28 Feb 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0526-2013 FDA Class II initiated 15 Nov 2012

    EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices.

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  • Withdrawn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
HCC
Device Class
Class II
Regulation
21 CFR Part 882.5050
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 EEG Neuroamp, Model CS10137, is a biofeedback device used in the field of neurology. It functions to monitor and process physiological signals for biofeedback applications.

This device is manufactured by Corscience GmbH & Co. KG and has received FDA 510(k) clearance. It is classified under regulation number 882.5050.

Other devices from Corscience GmbH & Co. KG

Questions

AI-generated answers, 23 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 is the primary function of the EEG Neuroamp CS10137?

    The EEG Neuroamp is a biofeedback device designed for use in the field of neurology. Its primary function is to monitor and process physiological signals to support biofeedback applications.

  • Who is the manufacturer of this device?

    The EEG Neuroamp, model CS10137, is manufactured by Corscience GmbH & Co. KG, which is based in Erlangen, Bavaria, Germany.

  • Has this device received regulatory authorization?

    Yes, the EEG Neuroamp, model CS10137, has received FDA 510(k) clearance. It is classified under regulation number 882.5050.