FDA 510(k)

Grass TWin

K号: K173690 · 2018-03-09

申请人Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

决定日期2018-03-09

产品代码OLV

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)为申报人的其他记录

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