FDA 510(k)

科米特-PLUS

K 號：K172711 · 2017-11-03

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

決定日期2017-11-03

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

Comet-PLUS 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 2017-11-03 under 510(k) number K172711. 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 Comet-PLUS?

Comet-PLUS is a medical device that received FDA 510(k) clearance on 2017-11-03. The listed applicant is Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The 510(k) number is K172711.

When did Comet-PLUS receive FDA 510(k) clearance?

Comet-PLUS received FDA 510(k) clearance on 2017-11-03, under 510(k) number K172711.

Who is the listed applicant for Comet-PLUS?

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 Comet-PLUS?

The FDA product code for Comet-PLUS is OLV.