Modified Brain Atlas III

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K854362 ↗

FDA Product Code

GWE

Device Class

Class II

Regulation

21 CFR Part 882.1890

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Sleepscan

  Class II

  FDA 510(k) K894155 Active Cleared 26 Jan 1990

• Disposable Cutaneous Electrodes

  Class II

  FDA 510(k) K941799 Active Cleared 3 Feb 1995

• Bio-Logic Master Evoked Response System

  Class II

  FDA 510(k) K021895 Active Cleared 1 Jul 2002

• Ceegraph Traveler Ambulatory EEG Recorder

  Class II

  FDA 510(k) K954954 Active Cleared 25 Jan 1996

• SLEEPSCAN Airflow Pressure Transducer

  Class II

  FDA 510(k) K971501 Active Cleared 14 Oct 1997

• Bio-Logic Sleepscan Product With Built-In Oximeter

  Class II

  FDA 510(k) K962103 Active Cleared 22 Aug 1996

See all devices from Bio-Logic Systems Corp. →

• What is the Modified Brain Atlas III used for?

  The Modified Brain Atlas III is a stimulator device used for evoked response testing in neurology. It measures brain activity in response to specific stimuli, providing diagnostic information for neurological conditions in clinical settings.

• How is the Modified Brain Atlas III supplied?

  The Modified Brain Atlas III is supplied by Bio-Logic Systems Corp. It is a Class II device designed for clinical use in neurological assessment and diagnosis, with FDA 510(k) clearance and product code GWE.

• What is the regulatory status of the Modified Brain Atlas III?

  The Modified Brain Atlas III is authorized under FDA 510(k) clearance with product code GWE. It was determined to be substantially equivalent to predicate devices and is classified as a Class II device for neurological assessment.

• What are the specifications of the Modified Brain Atlas III?

  The Modified Brain Atlas III is a stimulator device specifically designed for evoked response testing. It is manufactured by Bio-Logic Systems Corp. and has received FDA 510(k) clearance with the K number K854362, indicating it meets regulatory requirements for neurological diagnostic use.