FDA 510(k)

XN 藥品設備規範文本

K 號：K160585 · 2016-12-22

申請人Streck

決定日期2016-12-22

產品代碼KRX

諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。

決定相當於

器材摘要

XN CAL is the device name listed in this FDA 510(k) record. The listed applicant is Streck. It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K160585. The device is classified under product code KRX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the XN CAL?

XN CAL is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Streck. The 510(k) number is K160585.

When did XN CAL receive FDA 510(k) clearance?

XN CAL received FDA 510(k) clearance on 2016-12-22, under 510(k) number K160585.

Who is the listed applicant for XN CAL?

The FDA 510(k) record lists Streck as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XN CAL?

The FDA product code for XN CAL is KRX.

其他以 Streck 為申請人之記錄

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