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K Number
K122040
Device Name
INVOTEC LARYNGEAL ELECTRODE
Manufacturer
INVOTEC INTERNATIONAL, INC.
Date Cleared
2013-10-31

(476 days)

Product Code
ETN
Regulation Number
874.1820
Type
Traditional
Panel
EN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Invotec Laryngeal Electrodes are intended to be used as a sterile, single use, selfadhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of larynx during surgical procedure. This electrode is not to be adhesively attached to silicone endotracheal tubes.

Device Description

Not Found

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for the Invotec Laryngeal Electrode, stating its substantial equivalence to legally marketed predicate devices. It lists the indications for use but does not include any performance metrics, study designs, sample sizes, or ground truth establishment relevant to the questions asked.

Therefore, I cannot provide the requested information based on the input text.

§ 874.1820 Surgical nerve stimulator/locator.

(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.