Ceegraph Traveler Ambulatory EEG Recorder

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

510(k) Number

K954954 ↗

FDA Product Code

GWQ

Device Class

Class II

Regulation

21 CFR Part 882.1400

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

• 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

• Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro.

  Class II

  FDA 510(k) K994149 Active Cleared 27 Dec 1999

See all devices from Bio-Logic Systems Corp. →

• What is the primary function of the Ceegraph Traveler?

  The Ceegraph Traveler is a full-montage standard electroencephalograph. It is designed to measure and record the electrical activity of a patient's brain by utilizing electrodes placed on the head.

• Who is the manufacturer of this device?

  This device is manufactured by Bio-Logic Systems Corp., located in Mudelein, Illinois.

• What is the regulatory status of the Ceegraph Traveler?

  The Ceegraph Traveler has received FDA 510(k) clearance. It is classified as a Class 2 medical device under the neurology specialty.