FDA 510(k)

Natus量子

K 號：K180181 · 2018-02-22

申請人Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek)

決定日期2018-02-22

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

Natus Quantum 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 2018-02-22 under 510(k) number K180181. 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 Natus Quantum?

Natus Quantum is a medical device that received FDA 510(k) clearance on 2018-02-22. The listed applicant is Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek). The 510(k) number is K180181.

When did Natus Quantum receive FDA 510(k) clearance?

Natus Quantum received FDA 510(k) clearance on 2018-02-22, under 510(k) number K180181.

Who is the listed applicant for Natus Quantum?

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 Natus Quantum?

The FDA product code for Natus Quantum is GWQ.