← Back to catalogue

Smartep-Assr, Model M811007

FDA 510(k)

Class II (US FDA 510(k))

510(k) K031051

by Intelligent Hearing Systems

Identifiers

510(k) Number
K031051 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)

The SMARTEP-ASSR, MODEL M811007 is an auditory steady-state response system (ASSR) designed for diagnostic and screening purposes. It functions as a full-featured system that can be added to SmartEP software, which runs on IHS's Duet, Aria, and Solo hardware platforms. This device is classified as a Stimulator, Auditory, Evoked Response and is intended for use in neurology applications.

The SMARTEP-ASSR, MODEL M811007 is a Class 2 device that received FDA 510(k) clearance with the number K031051 on February 20, 2004. It is manufactured by Intelligent Hearing Systems and is regulated under product code GWJ with regulation number 882.1900. The device is supplied as part of the SmartEP system and is designed to work with IHS's hardware platforms for auditory evoked response testing.

Frequently asked questions

What clinical purpose does the SMARTEP-ASSR M811007 serve?

It provides auditory steady‑state response testing for diagnostic and screening applications in neurology, allowing clinicians to assess auditory pathway function through evoked response measurements.

How is the SMARTEP-ASSR M811007 supplied and what hardware does it require?

The device is supplied as part of the SmartEP system and is designed to be added to IHS’s SmartEP software. It operates on the Duet, Aria, or Solo hardware platforms, so users must have one of those compatible units to run the ASSR module.

Is the SMARTEP-ASSR M811007 a single‑use or reusable system?

The SMARTEP-ASSR M811007 is a reusable electronic stimulator; it is not a disposable component. Proper cleaning and maintenance of the hardware platform are required between patients according to the manufacturer’s instructions.

What regulatory clearance does the SMARTEP-ASSR M811007 have?

It received FDA 510(k) clearance (K031051) on February 20, 2004, classified as a Class 2 Stimulator, Auditory, Evoked Response device under product code GWJ and regulation number 882.1900.

What storage conditions are recommended for the SMARTEP-ASSR M811007?

The device should be stored in a clean, dry environment within the temperature range specified by the manufacturer’s user manual, typically standard room temperature, to preserve electronic performance and calibration stability.

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-ASSR, MODEL M811007 (K031051) — FDA 510(k) | Innolitics, SMARTEP-ASSR, MODEL M811007 510 (k) K031051 - FDA.report, SmartEP - Intelligent Hearing Systems, SmartEP-ASSR - Intelligent Hearing Systems

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Intelligent Hearing Systems

Sources (1)

  • FDA 510(k) K031051 24 fields · synced Sep 25, 2026