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Nystagmograph Eog/Eng Analyses

by Nicolet Biomedical Instruments

510(k) K851190

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 NumberK851190 Date27 Nov 1985ClearedStatusActive

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  • Withdrawn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
GWN
Device Class
Class II
Regulation
21 CFR Part 882.1460
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Nystagmograph Eog/Eng Analyses is a device used for electrooculography (EOG) and electroencephalography (ENG) analyses. It is classified as a class 2 device and is used in the field of neurology. The device is designed to record and analyze the electrical activity of the eyes and brain.

The device is supplied by Nicolet Biomedical Instruments and has been cleared by the FDA with a traditional clearance type. It has a regulation number of 882.1460 and a product code of GWN. The device is intended for use in a medical setting and is subject to the regulations and guidelines set forth by the FDA. The device has been assigned a K number of K851190 and has been deemed substantially equivalent by the FDA.

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Questions

AI-generated answers, 22 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 Nystagmograph EOG/ENG Analyses used for?

    The Nystagmograph EOG/ENG Analyses is used for electrooculography (EOG) and electroencephalography (ENG) analyses in the field of neurology, to record and analyze the electrical activity of the eyes and brain.

  • Is the Nystagmograph EOG/ENG Analyses cleared by the FDA?

    Yes, the Nystagmograph EOG/ENG Analyses has been cleared by the FDA with a traditional clearance type and has been assigned a K number of K851190, deemed substantially equivalent by the FDA.

  • What type of device is the Nystagmograph EOG/ENG Analyses?

    The Nystagmograph EOG/ENG Analyses is classified as a class 2 device.

  • What is the product code of the Nystagmograph EOG/ENG Analyses?

    The product code of the Nystagmograph EOG/ENG Analyses is GWN.