FDA 510(k)

Trex_HD

K 號：K162595 · 2016-11-04

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

決定日期2016-11-04

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

Trex_HD 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 2016-11-04 under 510(k) number K162595. 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 Trex_HD?

Trex_HD is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The 510(k) number is K162595.

When did Trex_HD receive FDA 510(k) clearance?

Trex_HD received FDA 510(k) clearance on 2016-11-04, under 510(k) number K162595.

Who is the listed applicant for Trex_HD?

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 Trex_HD?

The FDA product code for Trex_HD is GWQ.

其他以 Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) 為申請人之記錄

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