Medelec 2110 and 2114 EEG
510(k) K922548
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK922548 | Date3 Nov 1992 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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, 1 Oct 2026
The Medelec 2110 and 2114 EEG are Full-Montage Standard Electroencephalographs, designed to measure and record the electrical activity of the brain. These devices employ multiple electrodes placed on the scalp to capture and display brainwave patterns, aiding in the diagnosis and monitoring of neurological conditions. Their functionality aligns with standard EEG systems, providing critical data for clinical assessment in neurology.
These devices are intended for use in clinical settings, such as hospitals and neurology clinics, where trained professionals conduct EEG examinations. Supplied as reusable medical equipment, they require proper maintenance and calibration to ensure accurate readings. The Medelec 2110 and 2114 EEG are classified under FDA regulation 882.1400 as Class II devices, with a clearance granted under the 510(k) pathway (K922548) as substantially equivalent to predicate devices. No specific sterility or MRI safety information is provided in the data.
Other devices from Medelec Intl. Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the primary use of the Medelec 2110 and 2114 EEG systems?
The Medelec 2110 and 2114 EEG systems are designed to measure and record the electrical activity of the brain using multiple scalp electrodes. This data aids clinicians in diagnosing and monitoring neurological conditions, such as epilepsy, sleep disorders, or brain injuries, by providing detailed brainwave patterns for clinical assessment in neurology settings like hospitals and clinics.
Are the Medelec 2110 and 2114 EEG systems single-use or reusable?
The Medelec 2110 and 2114 EEG systems are reusable medical devices. Since they are intended for repeated use in clinical environments, they require regular maintenance, calibration, and cleaning to ensure accurate and reliable performance over time.
What regulatory pathway does the Medelec 2110 and 2114 EEG follow?
The Medelec 2110 and 2114 EEG systems are classified as Class II devices under FDA regulation 882.1400. They were granted clearance through the 510(k) pathway, specifically as substantially equivalent to predicate devices, with the clearance number K922548. This classification ensures they meet stringent safety and performance standards for use in clinical diagnostics.
Do the Medelec 2110 and 2114 EEG systems come with any specific sterility or MRI safety information?
The provided data does not include any specific information regarding sterility or MRI safety for the Medelec 2110 and 2114 EEG systems. Clinicians should verify compatibility with their facility’s MRI protocols and follow standard infection control practices for reusable medical equipment.
What types of clinical settings are these EEG systems intended for?
The Medelec 2110 and 2114 EEG systems are specifically designed for use in clinical settings such as hospitals, neurology clinics, and diagnostic centers. These environments require trained professionals to conduct EEG examinations, ensuring accurate interpretation of brainwave data for neurological assessments.