FDA 510(k)

自動記錄 IQ 自動輸血系統

K 號：K181954 · 2018-08-22

決定日期2018-08-22

產品代碼CAC

諮詢委員會AN

決定相當於

器材摘要

autoLog IQ Autotransfusion System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Perfusion Systems. It received FDA 510(k) clearance on 2018-08-22 under 510(k) number K181954. 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 autoLog IQ Autotransfusion System?

autoLog IQ Autotransfusion System is a medical device that received FDA 510(k) clearance on 2018-08-22. The listed applicant is Medtronic Perfusion Systems. The 510(k) number is K181954.

When did autoLog IQ Autotransfusion System receive FDA 510(k) clearance?

autoLog IQ Autotransfusion System received FDA 510(k) clearance on 2018-08-22, under 510(k) number K181954.

Who is the listed applicant for autoLog IQ Autotransfusion System?

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

What is the FDA product code for autoLog IQ Autotransfusion System?

The FDA product code for autoLog IQ Autotransfusion System is CAC.

其他以 Medtronic Perfusion Systems 為申請人之記錄

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相關器械（代碼：CAC）

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