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FDA 510(k)

XLTEK EMU40EX EEG Headbox

K-Number: K163163 · 2016-12-14

ApplicantNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Decision Date2016-12-14
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

XLTEK EMU40EX EEG Headbox is the device name listed in this FDA 510(k) record. The listed applicant is Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). It received FDA 510(k) clearance on 2016-12-14 under 510(k) number K163163. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XLTEK EMU40EX EEG Headbox?

XLTEK EMU40EX EEG Headbox is a medical device that received FDA 510(k) clearance on 2016-12-14. The listed applicant is Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The 510(k) number is K163163.

When did XLTEK EMU40EX EEG Headbox receive FDA 510(k) clearance?

XLTEK EMU40EX EEG Headbox received FDA 510(k) clearance on 2016-12-14, under 510(k) number K163163.

Who is the listed applicant for XLTEK EMU40EX EEG Headbox?

The FDA 510(k) record lists Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XLTEK EMU40EX EEG Headbox?

The FDA product code for XLTEK EMU40EX EEG Headbox is GWQ.

Other records listing Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) as applicant

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Related Devices (Code: GWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity SasK221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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