FDA 510(k)

背景圖案分類 [BPc™]

K 號：K152301 · 2016-06-03

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

決定日期2016-06-03

產品代碼OMA

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

Background Pattern Classification [BPc(TM)] 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 2016-06-03 under 510(k) number K152301. The device is classified under product code OMA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Background Pattern Classification [BPc(TM)]?

Background Pattern Classification [BPc(TM)] is a medical device that received FDA 510(k) clearance on 2016-06-03. The listed applicant is Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The 510(k) number is K152301.

When did Background Pattern Classification [BPc(TM)] receive FDA 510(k) clearance?

Background Pattern Classification [BPc(TM)] received FDA 510(k) clearance on 2016-06-03, under 510(k) number K152301.

Who is the listed applicant for Background Pattern Classification [BPc(TM)]?

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 Background Pattern Classification [BPc(TM)]?

The FDA product code for Background Pattern Classification [BPc(TM)] is OMA.