SLS 3500 LED Visual Stimulator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K842381 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 SLS 3500 LED Visual Stimulator is a photic stimulator used for evoked response testing in neurology. It is classified as a Class II medical device under FDA regulation 882.1890.
The device received traditional 510(k) clearance (K842381) from the FDA on November 9, 1984, following a 144-day review. It is manufactured by Nihon Kohden America, Inc. and is intended for use in clinical neurology settings for visual evoked potential testing.
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: SLS 3500 LED VISUAL STIMULATOR (K842381) - FDA 510 (k), 510(k) K842381 — SLS 3500 LED VISUAL STIMULATOR - RegDataLab, PDF K842381 - Sls 3500 Led Visual Stimulator, Supplies & Accessories - NIHON KOHDEN GLOBAL, Contact Us - NIHON KOHDEN GLOBAL
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K842381 | Class II | Active |
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Manufacturer
- Manufacturer
- Nihon Kohden America, Inc.
Sources (1)
- FDA 510(k) K842381 24 fields · synced Sep 26, 2026