FDA 510(k)

autoLog IQ 自动输血系统

K号: K181954 · 2018-08-22

决定日期2018-08-22

产品代码CAC

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决定实质等同

器械摘要

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.

常见问题

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.

列明Medtronic Perfusion Systems为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K240666Affinity Fusion 氧合器带集成动脉过滤器和平衡生物表面（BB811）；Affinity Fusion 氧合器带集成动脉过滤器、心室/静脉储液器和平衡生物表面（BB841）；Affinity Fusion 氧合器带集成动脉过滤器和平衡生物表面非无菌（BB811-NS）

官方来源

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