FDA 510(k)

Grass TWin

K 號：K173690 · 2018-03-09

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

決定日期2018-03-09

產品代碼OLV

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

Grass TWin 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 2018-03-09 under 510(k) number K173690. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Grass TWin?

Grass TWin is a medical device that received FDA 510(k) clearance on 2018-03-09. The listed applicant is Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The 510(k) number is K173690.

When did Grass TWin receive FDA 510(k) clearance?

Grass TWin received FDA 510(k) clearance on 2018-03-09, under 510(k) number K173690.

Who is the listed applicant for Grass TWin?

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 Grass TWin?

The FDA product code for Grass TWin is OLV.