Identifiers
- 510(k) Number
- K033052 FDA 510(k)
- FDA Product Code
- GYB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1275 FDA 510(k)
- Regulation Number
- 882.1275 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Conductive EEG Electrolyte is an electroconductive medium designed for use in electroencephalography (EEG) recordings. It facilitates the transmission of electrical signals between EEG electrodes and the scalp, ensuring accurate and reliable brainwave measurements during neurological assessments.
This product is supplied as a gel or paste and is intended for single-use applications in clinical settings. It is classified under 21 CFR 882.1275 and has received FDA 510(k) clearance (K033052) as substantially equivalent to a predicate device. The product code assigned is GYB, and it is regulated for use in neurology procedures.
Frequently asked questions
What is the Conductive EEG Electrolyte used for in clinical settings?
The Conductive EEG Electrolyte is specifically designed to facilitate the transmission of electrical signals between EEG electrodes and the scalp during neurological assessments. It ensures accurate and reliable brainwave measurements, which are critical for diagnosing and monitoring neurological conditions.
Is the Conductive EEG Electrolyte intended for single-use or reusable applications?
The Conductive EEG Electrolyte is explicitly intended for single-use applications in clinical settings. This design ensures patient safety and hygiene, as it prevents cross-contamination between uses.
How is the Conductive EEG Electrolyte supplied, and what forms does it come in?
The Conductive EEG Electrolyte is supplied as either a gel or paste, providing flexibility in application depending on clinical needs. Both forms are optimized to maintain conductivity between electrodes and the scalp for EEG recordings.
What regulatory pathway was followed for FDA clearance of this product?
The Conductive EEG Electrolyte received FDA 510(k) clearance (K033052) under an abbreviated review process, demonstrating it is substantially equivalent to a predicate device. The product is classified under 21 CFR 882.1275 and falls under the Neurology advisory committee (NE).
Are there multiple sizes or models of this Conductive EEG Electrolyte, or is it a single formulation?
The provided data does not specify distinct sizes or models, but the product code (GYB) and registration numbers indicate multiple FEI (Facility Establishment Identifier) records, suggesting variations may exist (e.g., different packaging or batch formulations). Clinicians should confirm the exact formulation or size required for their EEG procedures.
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: CONDUCTIVE EEG ELECTROLYTE (K033052) — FDA 510(k) | Innolitics, CONDUCTIVE EEG ELECTROLYTE 510 (k) K033052 - FDA.report, Compumedics USA, Ltd. · DeviceClearance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K033052 | Class II | Active |
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Manufacturer
- Manufacturer
- Compumedics USA, Ltd.
Sources (1)
- FDA 510(k) K033052 24 fields · synced Sep 19, 2026