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Evox Electro Diagnostic Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K082614

by Laborie Medical Technologies, Inc.

Identifiers

510(k) Number
K082614 FDA 510(k)
FDA Product Code
GWF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1870 FDA 510(k)
Regulation Number
882.1870 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Evox Electro Diagnostic Device is an Electrical, Evoked Response Stimulator used for diagnostic purposes. It utilizes Laborie Urodynamic equipment or another compatible microprocessor to perform evaluation tests. The device is classified as a Class 2 device. It is used in the field of Neurology.

The Evox Electro Diagnostic Device is supplied by Laborie Medical Technologies, Inc. and has been granted FDA 510(k) clearance. The device is registered with the FDA under the product code GWF and regulation number 882.1870. It is intended for use in a medical setting, but specific details on sterility, single-use or reusable status, and storage are not provided.

Frequently asked questions

What is the Evox Electro Diagnostic Device used for?

The Evox Electro Diagnostic Device is used for diagnostic purposes in the field of neurology, specifically as an electrical evoked response stimulator.

Is the Evox Electro Diagnostic Device sterile?

Specific details on sterility are not provided, it is recommended to consult the manufacturer or medical professional for more information.

What kind of clearance does the Evox Electro Diagnostic Device have?

The Evox Electro Diagnostic Device has been granted FDA 510(k) clearance, indicating it is substantially equivalent to a predicate device.

How is the Evox Electro Diagnostic Device supplied?

The Evox Electro Diagnostic Device is supplied by Laborie Medical Technologies, Inc.

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: EVOX ELECTRO DIAGNOSTIC DEVICE (K082614) — FDA 510 (k) | Innolitics, Evox Electro Diagnostic Device 510 (k) FDA Premarket Notification ..., 510 (k) Premarket Notification - Food and Drug Administration, PDF 510(k) Summary - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Laborie Medical Technologies, Inc.

Sources (1)

  • FDA 510(k) K082614 24 fields · synced Sep 26, 2026