Trex HD

FDA 510(k)

Class II (US FDA 510(k))

510(k) K162595

by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek)

Identifiers

510(k) Number: K162595 FDA 510(k)
FDA Product Code: GWQ FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 882.1400 FDA 510(k)
Regulation Number: 882.1400 FDA 510(k)
Advisory Committee: Neurology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Trex HD is a full-montage standard electroencephalograph. It functions as a monitoring amplifier designed to record and analyze electrical activity of the brain.

This device is manufactured by Natus Medical Incorporated and has received FDA 510k clearance. It is intended for use in clinical settings as outlined in the provided user and service manual.

Frequently asked questions

What is the primary function of the Trex HD?

The Trex HD is a full-montage standard electroencephalograph that functions as a monitoring amplifier. It is designed to record and analyze the electrical activity of the brain.

In what environment is the Trex HD intended to be used?

The device is intended for use in clinical settings. Users should refer to the provided user and service manual for specific operational guidelines and clinical applications.

What is the regulatory status of the Trex HD?

The Trex HD has received FDA 510k clearance under the product code GWQ and regulation number 882.1400, as documented in the device data.

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: NATUS XLTEK TREX HD USER & SERVICE MANUAL Pdf Download, Natus XLTEK Trex HD Instructions for use - manualzz, NATUS XLTEK TREX HD USER & SERVICE MANUAL Pdf Download, Trex™ HD Video Ambulatory System - Natus Medical - PDF Catalogs ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K162595	Class II	Active

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Manufacturer

Manufacturer: Natus Medical Incorporated Dba Excel-Tech Ltd (xltek)
FDA Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

Sources (1)

FDA 510(k) K162595 24 fields · synced Sep 25, 2026