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K Number
K980214
Device Name
EXCEL NEURO WORKS
Manufacturer
EXCEL TECH. LTD.
Date Cleared
1998-04-21

(90 days)

Product Code
GWQ
Regulation Number
882.1400
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The NeuroWorks EEG is an electroencephalograph which is designed to display the electrical signals of the brain.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device named "NeuroWorks EEG". It's a regulatory approval document and does not contain information about acceptance criteria or a study proving that the device meets such criteria. Therefore, I cannot extract the requested information from the provided text.

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).