FDA 510(k)

XLTEK EMU40EX 腦電圖頭箱

K 號：K163163 · 2016-12-14

申請人Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

決定日期2016-12-14

產品代碼GWQ

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

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.

常見問題

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.