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FDA 510(k)

Trex_HD

K-Number: K162595 · 2016-11-04

ApplicantNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Decision Date2016-11-04
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Trex_HD 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 2016-11-04 under 510(k) number K162595. 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 Trex_HD?

Trex_HD is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The 510(k) number is K162595.

When did Trex_HD receive FDA 510(k) clearance?

Trex_HD received FDA 510(k) clearance on 2016-11-04, under 510(k) number K162595.

Who is the listed applicant for Trex_HD?

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 Trex_HD?

The FDA product code for Trex_HD 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.

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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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