XLTEK EMU40EX EEG Headbox

FDA 510(k)

Class II (US FDA 510(k))

510(k) K163163

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

Identifiers

510(k) Number: K163163 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 XLTEK EMU40EX EEG Headbox is a full-montage standard electroencephalograph device classified as Class II under FDA regulation number 882.1400. It is designed for the acquisition of electroencephalographic signals in neurology applications.

The device received FDA 510(k) clearance (K163163) on December 14, 2016, and was found substantially equivalent to a predicate device. It is manufactured by Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) and is intended for use in clinical neurology settings as specified in its authorization and device classification.

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® EMU40EX™ Wireless LTM Amplifier, NATUS XLTEK EMU40EX USER AND SERVICE MANUAL Pdf Download, Xltek EMU40EX User and Service Manual - Natus | Manualzz, NATUS EMU40EX USER MANUAL Pdf Download | ManualsLib

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	K163163	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) K163163 24 fields · synced Sep 24, 2026