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K Number
K042150
Device Name
XLTEK TREX MODEL#10309
Manufacturer
EXCEL TECH. LTD.
Date Cleared
2004-08-27

(18 days)

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

The XLTEK TREX is intended to be used as an electroencephalograph: to acquire, display, store and archive electroencephalographic signals.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for the XLTEK Trex, an electroencephalograph device. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested.

Therefore, I cannot fulfill your request for this specific document.

§ 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).