FDA 510(k)

XLTEK EMU40EX 脑电图头盒

K号: K163163 · 2016-12-14

申请人Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

决定日期2016-12-14

产品代码GWQ

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决定实质等同

器械摘要

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.

常见问题

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.

列明Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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