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SmartEP

FDA 510(k)

Class II (US FDA 510(k))

510(k) K163326

by Intelligent Hearing Systems

Identifiers

510(k) Number
K163326 FDA 510(k)
FDA Product Code
GWJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1900 FDA 510(k)
Regulation Number
882.1900 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

SmartEP is a Stimulator, Auditory, Evoked Response device. It is designed for the acquisition of Auditory, Visual, and Somatosensory Evoked Potentials and supports ABR and evoked potential acquisition on IHS's Duet, Aria, and Solo hardware platforms.

SmartEP is supplied as software for use with specified hardware platforms. It is intended for clinical and research settings, with authorisations including FDA 510(k) clearance under k-number K163326 and product code GWJ, and is classified as a Class II device under regulation number 882.1900.

Frequently asked questions

What is SmartEP used for?

SmartEP is designed for the acquisition of auditory, visual, and somatosensory evoked potentials, including ABR and other evoked potential measurements. It supports clinical and research applications when used with compatible IHS hardware platforms such as Duet, Aria, and Solo.

How is SmartEP supplied and what hardware is it compatible with?

SmartEP is supplied as software only and is intended for use with specific IHS hardware platforms: Duet, Aria, and Solo. It does not include hardware and must be installed on these systems to function for evoked potential acquisition.

Is SmartEP a single-use or reusable device?

SmartEP is software and therefore not subject to single-use or reuse limitations in the same way as physical devices. It can be reinstalled and used repeatedly on compatible hardware platforms as long as it remains functional and properly licensed.

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: SmartEP - Intelligent Hearing Systems, SmartEP - Intelligent Hearing Systems, SmartEP - Intelligent Hearing Systems - PDF Catalogs | Technical ..., ABR screening system - SmartEP - Intelligent Hearing Systems - for ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Intelligent Hearing Systems

Sources (1)

  • FDA 510(k) K163326 24 fields · synced Sep 27, 2026