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K Number
K111737
Device Name
DISPOSABLE ELECTRODE
Manufacturer
SANIBEL SUPPLY
Date Cleared
2011-10-14

(115 days)

Product Code
GXY
Regulation Number
882.1320
Type
Special
Panel
NE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Disposable adhesive electrode for standard neurophysiological examinations

Device Description

Disposable Electrode

AI/ML Overview

The provided text {0-2} describes an FDA 510(k) premarket notification for the "Sanibel Disposable Electrodes." It includes information about the device's classification, regulation number, and indications for use.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt regarding a study proving the device meets acceptance criteria.

This document is a regulatory approval letter and an "Indications for Use" statement, not a scientific study report. Therefore, I cannot generate the requested table and study description based on the provided text.

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).