FDA 510(k)

CATSmart

K 號：K160735 · 2016-09-16

決定日期2016-09-16

產品代碼CAC

諮詢委員會AN

決定相當於

器材摘要

CATSmart is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Kabi AG. It received FDA 510(k) clearance on 2016-09-16 under 510(k) number K160735. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CATSmart?

CATSmart is a medical device that received FDA 510(k) clearance on 2016-09-16. The listed applicant is Fresenius Kabi AG. The 510(k) number is K160735.

When did CATSmart receive FDA 510(k) clearance?

CATSmart received FDA 510(k) clearance on 2016-09-16, under 510(k) number K160735.

Who is the listed applicant for CATSmart?

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

What is the FDA product code for CATSmart?

The FDA product code for CATSmart is CAC.

其他以 Fresenius Kabi AG 為申請人之記錄

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相關器械（代碼：CAC）

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