Model 100 Visual Evoked Response Recording System
by Eyetronics, Inc. 510(k)
Active
510(k) K872725
Overview
The Model 100 Visual Evoked Response Recording System is a photic stimulator used to generate and display shifting patterns or apply brief light stimuli to a patient's eye. It is designed for use in evoked response measurements or for electroencephalogram (EEG) activation.
This device is classified as a Class II medical device under regulation number 882.1890. It has received FDA 510(k) clearance under the product code GWE.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK872725 | Date14 Aug 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GWE
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1890
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the primary function of the Model 100?
The Model 100 is a photic stimulator designed to generate and display shifting patterns or brief light stimuli to a patient's eye. It is specifically intended for use during evoked response measurements or for electroencephalogram (EEG) activation.
What is the regulatory status of this device?
The Model 100 Visual Evoked Response Recording System is a Class II medical device that has received FDA 510(k) clearance under product code GWE. It is regulated under 21 CFR 882.1890.
Which medical specialty uses this system?
This device is categorized under the neurology medical specialty. It is designed to assist clinicians in performing neurological assessments that require visual stimulation for evoked response or EEG procedures.