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Tomey PE-400 Portable ERG & VEP With Optional PS-4

FDA 510(k)

Class II (US FDA 510(k))

510(k) K932571

by Tomey Corporation USA

Identifiers

510(k) Number
K932571 FDA 510(k)
FDA Product Code
GWE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1890 FDA 510(k)
Regulation Number
882.1890 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Tomey PE-400 Portable ERG & VEP With Optional PS-4 is a portable device used for electroretinography (ERG) and visual evoked potential (VEP) testing. It is designed to measure electrical responses of the retina and visual pathway to light stimulation. This device is classified as a stimulator for evoked response in the neurology specialty.

The device is supplied by Tomey Corporation USA and has received FDA 510(k) clearance with product code GWE. It is a Class II medical device that can be used in various clinical settings. The device includes optional PS-4 functionality and is portable for ease of use in different environments.

Frequently asked questions

What is the Tomey PE-400 Portable ERG & VEP used for?

The Tomey PE-400 is a portable device designed to measure electrical responses of the retina and visual pathway to light stimulation through electroretinography (ERG) and visual evoked potential (VEP) testing.

What are the key features of the Tomey PE-400?

The device is portable for use in various clinical settings, includes optional PS-4 functionality, and is classified as a stimulator for evoked response in the neurology specialty.

What is the regulatory status of the Tomey PE-400?

The Tomey PE-400 has received FDA 510(k) clearance with product code GWE and is classified as a Class II medical device for use in evoked response testing in neurology.

How is the Tomey PE-400 supplied?

The device is supplied by Tomey Corporation USA and includes optional PS-4 functionality, making it versatile for different clinical environments while maintaining portability.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Tomey Pe-400 Portable Erg & Vep With Optional Ps-4, Tomey Pe-400 Portable Erg & Vep With Optional Ps-4, FDA 510 (k), K932571, TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4, fda.innolitics.com, Tomey Corporation USA FDA 510 (k) Products (1991-1997)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Tomey Corporation USA

Sources (1)

  • FDA 510(k) K932571 24 fields · synced Sep 28, 2026