FDA 510(k)

Artis zee/zeego & Artis Q/Q.zen

K 號：K181407 · 2018-08-15

決定日期2018-08-15

產品代碼OWB

諮詢委員會RA

決定相當於

器材摘要

Artis zee/zeego & Artis Q/Q.zen is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solution USA, Inc.. It received FDA 510(k) clearance on 2018-08-15 under 510(k) number K181407. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Artis zee/zeego & Artis Q/Q.zen?

Artis zee/zeego & Artis Q/Q.zen is a medical device that received FDA 510(k) clearance on 2018-08-15. The listed applicant is Siemens Medical Solution USA, Inc.. The 510(k) number is K181407.

When did Artis zee/zeego & Artis Q/Q.zen receive FDA 510(k) clearance?

Artis zee/zeego & Artis Q/Q.zen received FDA 510(k) clearance on 2018-08-15, under 510(k) number K181407.

Who is the listed applicant for Artis zee/zeego & Artis Q/Q.zen?

The FDA 510(k) record lists Siemens Medical Solution USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Artis zee/zeego & Artis Q/Q.zen?

The FDA product code for Artis zee/zeego & Artis Q/Q.zen is OWB.

其他以 Siemens Medical Solution USA, Inc. 為申請人之記錄

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相關器械（代碼：OWB）

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