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Electroencephalograph Accutrace 100

by Beckman Instruments, Inc. 510(k)

Active United States

510(k) K781041

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK781041 Date28 Jun 1978ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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, 19 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 Electroencephalograph Accutrace 100 is a full-montage standard electroencephalograph device used for recording electrical activity of the brain. It is designed to capture and display brain wave patterns for diagnostic purposes in neurological examinations.

This device is supplied by Beckman Instruments, Inc. and is classified as a Class II medical device. It is authorized under FDA 510(k) clearance K781041 with the product code GWQ. The device is intended for use in clinical settings and is regulated under 882.1400.

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