Trex_HD
K-Number: K162595 · 2016-11-04
Decision Date2016-11-04
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Trex_HD is a medical device manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). It received FDA 510(k) clearance on 2016-11-04 under approval 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. It is manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The 510(k) number is K162595.
When was Trex_HD approved by the FDA?
Trex_HD received FDA 510(k) clearance on 2016-11-04, under approval number K162595.
What company makes Trex_HD?
Trex_HD is manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek).
What is the FDA product code for Trex_HD?
The FDA product code for Trex_HD is GWQ.
Other Devices by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
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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.