Identifiers
- 510(k) Number
- K904926 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 an auditory evoked response stimulator device. It is designed for the acquisition of auditory, visual, and somatosensory evoked potentials.
SmartEP is supplied as software that runs on IHS's Duet, Aria, and Solo hardware platforms. It is used in clinical and research settings for evoked potential testing. The device received FDA 510(k) clearance under K904926 and is classified as a Class II device under regulation number 882.1900 with product code GWJ.
Frequently asked questions
What is SmartEP used for?
SmartEP is designed for the acquisition of auditory, visual, and somatosensory evoked potentials, enabling clinicians and researchers to assess neural responses to sensory stimuli in diagnostic and investigative applications.
How is SmartEP supplied and what hardware does it require?
SmartEP is supplied as software that operates on Intelligent Hearing Systems' Duet, Aria, and Solo hardware platforms, meaning it requires one of these specific systems to function and is not a standalone device.
Is SmartEP intended for clinical or research use?
SmartEP is used in both clinical and research settings for evoked potential testing, supporting applications such as neurological assessment, intraoperative monitoring, and scientific studies of sensory processing.
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, Home - Intelligent Hearing Systems, SmartEP - Intelligent Hearing Systems - PDF Catalogs | Technical ..., ABR screening system - SmartEP - Intelligent Hearing Systems - for ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K904926 | Class II | Active |
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Manufacturer
- Manufacturer
- Intelligent Hearing Systems
Sources (1)
- FDA 510(k) K904926 24 fields · synced Sep 22, 2026