Electroencephalograph Recording System

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

510(k) Number

K920127 ↗

FDA Product Code

GWQ

Device Class

Class II

Regulation

21 CFR Part 882.1400

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Medelec 2110 and 2114 EEG

  Class II

  FDA 510(k) K922548 Active Cleared 3 Nov 1992

• Sapphire 4ME EMG/Ep System

  Class II

  FDA 510(k) K912775 Active Cleared 8 Nov 1991

• Blade, Scalpel

  Class I

  FDA 510(k) K854561 Active Cleared 2 Dec 1985

• Prophylactic (Condom) MR. Johnny

  Class II

  FDA 510(k) K865106 Active Cleared 20 May 1987

• Prophylactic Condom

  Class II

  FDA 510(k) K854622 Active Cleared 11 Apr 1986

• Blades, Scalpel Carbon Steet

  Class I

  FDA 510(k) K854860 Active Cleared 24 Dec 1985

See all devices from Medelec Intl. Corp. →

• What is the Medelec EEG Full-Montage System used for?

  The Medelec EEG Full-Montage System is a Class II medical device designed to record and monitor electrical brain activity (electroencephalogram or EEG). Clinicians use it to diagnose and evaluate neurological conditions such as epilepsy, sleep disorders, and brain injuries. By placing multiple electrodes on the scalp, the system detects and amplifies brain wave patterns, enabling real-time visualization and analysis for clinical assessments in neurology.

• Is the Medelec EEG Full-Montage System single-use or reusable?

  The Medelec EEG Full-Montage System can be configured for either single-use or reusable applications, depending on the specific model and accessories included. The manufacturer provides flexibility to accommodate different clinical workflows and infection control protocols. Always follow manufacturer guidelines and facility policies for proper cleaning, sterilization, or disposal procedures.

• What models or configurations are available for the Medelec EEG Full-Montage System?

  The Medelec EEG Full-Montage System includes multiple model variants, each identified by a unique FEI number (e.g., 3005550372, 3020223448, etc.). These models may vary in features, electrode configurations, or connectivity options. For precise specifications, refer to the manufacturer’s documentation or consult a representative, as the system supports a wide range of clinical applications in neurology settings.

• Does the Medelec EEG Full-Montage System require special storage conditions?

  The Medelec EEG Full-Montage System is designed for use in standard clinical environments, including hospitals and neurology clinics. While no specific sterility or MRI safety information is provided in the data, compliance with regulatory requirements ensures safe operation. Store the device in a clean, dry location away from extreme temperatures or direct sunlight, and follow the manufacturer’s instructions for maintenance and calibration to preserve performance.

• How is the Medelec EEG Full-Montage System regulated?

  The Medelec EEG Full-Montage System holds FDA 510(k) clearance (K920127) under the classification 882.1400, with review by the Neurology Advisory Committee. This classification confirms it meets regulatory standards for safety and effectiveness as a Full-Montage Standard Electroencephalograph. Always refer to the latest regulatory documentation for compliance details, as requirements may evolve.