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Spectral EEG Monitor Model B500

by Biometrak Corp.

510(k) K913051

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 NumberK913051 Date20 Aug 1991ClearedStatusActive

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  • Withdrawn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
OLT
Device Class
Class II
Regulation
21 CFR Part 882.1400
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Spectral EEG Monitor Model B500 is a non-normalizing quantitative electroencephalograph software device used for monitoring brain activity through spectral analysis of EEG signals. It is designed to provide quantitative measurements of electrical activity in the brain for diagnostic purposes in neurology.

This device is supplied by Biometrak Corp. and is classified as a Class II medical device. It received FDA 510(k) clearance on August 20, 1991, with product code OLT. The device is intended for use in clinical settings where EEG monitoring is required, though specific sterility, single-use or reusable status, MRI safety, and storage details are not provided in the available data.

Questions

AI-generated answers, 24 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 Spectral EEG Monitor Model B500 used for?

    The Spectral EEG Monitor Model B500 is used for monitoring brain activity through spectral analysis of EEG signals for diagnostic purposes in neurology.

  • Is the Spectral EEG Monitor Model B500 a single-use or reusable device?

    The specific sterility, single-use or reusable status of the Spectral EEG Monitor Model B500 is not provided in the available data.

  • What type of clearance did the Spectral EEG Monitor Model B500 receive?

    The Spectral EEG Monitor Model B500 received FDA 510(k) clearance on August 20, 1991, with product code OLT.

  • In what settings is the Spectral EEG Monitor Model B500 intended for use?

    The Spectral EEG Monitor Model B500 is intended for use in clinical settings where EEG monitoring is required.