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FDA 510(k)

Natus Brain Monitor Amplifier

K-Number: K180290 · 2018-06-14

ApplicantNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Decision Date2018-06-14
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Natus Brain Monitor Amplifier is a medical device manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). It received FDA 510(k) clearance on 2018-06-14 under approval number K180290. 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 Natus Brain Monitor Amplifier?

Natus Brain Monitor Amplifier is a medical device that received FDA 510(k) clearance on 2018-06-14. It is manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The 510(k) number is K180290.

When was Natus Brain Monitor Amplifier approved by the FDA?

Natus Brain Monitor Amplifier received FDA 510(k) clearance on 2018-06-14, under approval number K180290.

What company makes Natus Brain Monitor Amplifier?

Natus Brain Monitor Amplifier is manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek).

What is the FDA product code for Natus Brain Monitor Amplifier?

The FDA product code for Natus Brain Monitor Amplifier is GWQ.

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Other Devices by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

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Related Devices (Code: GWQ)

K163163XLTEK EMU40EX EEG HeadboxNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) K162595Trex_HDNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) K150498Discovery 24Brainmaster Technologies, Inc. K170138NEURONAUTEBioserenity K171781eVox SystemEvoke Neuroscience, Inc. K171124Nihon Kohden Wireless Input Unit WEE-1200Nihon Kohden Corporation

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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