XLTEK EMU40EX EEG Headbox
K-Number: K163163 · 2016-12-14
Decision Date2016-12-14
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
XLTEK EMU40EX EEG Headbox is a medical device manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). It received FDA 510(k) clearance on 2016-12-14 under approval 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. It is manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The 510(k) number is K163163.
When was XLTEK EMU40EX EEG Headbox approved by the FDA?
XLTEK EMU40EX EEG Headbox received FDA 510(k) clearance on 2016-12-14, under approval number K163163.
What company makes XLTEK EMU40EX EEG Headbox?
XLTEK EMU40EX EEG Headbox is manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek).
What is the FDA product code for XLTEK EMU40EX EEG Headbox?
The FDA product code for XLTEK EMU40EX EEG Headbox is GWQ.
Other Devices by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Related Devices (Code: GWQ)
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.