Reusable Finger Clip Recording Electrode
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K925706 FDA 510(k)
- FDA Product Code
- GXY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1320 FDA 510(k)
- Regulation Number
- 882.1320 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A reusable finger clip recording electrode is a cutaneous electrode applied directly to a patient's skin to record physiological signals such as the electroencephalogram. It is designed for repeated use after appropriate cleaning and disinfection between uses.
This device is supplied non-sterile and intended for use in clinical settings such as neurology environments. It is regulated under FDA 510(k) clearance K925706, with product code GXY, and was cleared on February 10, 1993, as substantially equivalent to a predicate device.
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: REUSABLE FINGER CLIP RECORDING ELECTRODE (K925706) — FDA 510 (k ..., Reusable Finger Clip Recording Electrode 510 (k) FDA Premarket ..., 510(k) Premarket Notification, Chalgren Enterprises, Inc. - FDA 510 (k) Cleared Devices
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K925706 | Class II | Active |
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Manufacturer
- Manufacturer
- Chalgren Enterprises, Inc.
Sources (1)
- FDA 510(k) K925706 24 fields · synced Sep 23, 2026