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Bio-Logic Ceegraph 128-CHANNEL Recording System

by Bio-Logic Systems Corp.

510(k) K973883

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 NumberK973883 Date5 Mar 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  • Withdrawn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, 26 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 Bio-Logic Ceegraph 128-Channel Recording System is a full-montage standard electroencephalograph designed to capture, record, and analyze electrical brain activity. It utilizes up to eight 16-channel analog boards to provide signal amplification and patient isolation, accepting inputs from electrode arrays attached to the patient's scalp.

This system is indicated for use in routine EEG tests and continuous long-term EEG monitoring, including patient video. It is authorized via FDA 510(k) clearance under K973883.

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