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BMS-2000 Mobile EEG System

by Buckman Co., Inc. 510(k)

Active United States

510(k) K891405

Overview

The BMS-2000 Mobile EEG System is an Encephalogram Telemetry System, classified under product code GYE for neurology applications. It is designed to record and transmit electroencephalogram (EEG) data, enabling continuous monitoring of brain electrical activity in mobile or non-laboratory settings. This portable device supports clinical assessments for neurological conditions by providing real-time diagnostic information. Its classification as a Class 2 device reflects its role in specialized neurological evaluations.

This system is supplied as a mobile unit for use in clinical or ambulatory settings, where portability is essential for patient monitoring outside traditional EEG labs. The device is intended for single-use or reusable configurations, though sterility specifications are not detailed in the provided data. It adheres to FDA clearance under 510(k) K891405, filed under the Traditional pathway in 1989, and is regulated under 21 CFR 882.1855 for encephalogram telemetry systems. No MRI safety or size-specific storage instructions are noted in the available documentation.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK891405 Date2 Aug 1989ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1225-2007 FDA Unclassified (pre-2012) initiated 17 Jul 2007 via K891405, on the same 510(k)

    The BMSI "MicroJack" patient interface electrode connection device used with the EEG monitor systems was found to be mis-wired. A complainant alleged that during depth electrode EEG study of a patient in preparation for brain surgery there was an observation that was perceived as non-logical data output.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
GYE
Device Class
Class II
Regulation
21 CFR Part 882.1855
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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