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FDA 510(k)

Aquilion ONE (TSX-305A/3) V7.3

K号: K160587 · 2016-06-09

决定日期2016-06-09
产品代码JAK
咨询委员会RA
决定实质等同

器械摘要

Aquilion ONE (TSX-305A/3) V7.3 is the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2016-06-09 under 510(k) number K160587. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Aquilion ONE (TSX-305A/3) V7.3?

Aquilion ONE (TSX-305A/3) V7.3 is a medical device that received FDA 510(k) clearance on 2016-06-09. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K160587.

When did Aquilion ONE (TSX-305A/3) V7.3 receive FDA 510(k) clearance?

Aquilion ONE (TSX-305A/3) V7.3 received FDA 510(k) clearance on 2016-06-09, under 510(k) number K160587.

Who is the listed applicant for Aquilion ONE (TSX-305A/3) V7.3?

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

What is the FDA product code for Aquilion ONE (TSX-305A/3) V7.3?

The FDA product code for Aquilion ONE (TSX-305A/3) V7.3 is JAK.

相关临床试验

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列明Toshibamedical Systems Corporation为申报人的其他记录

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相关器械(代码:JAK)

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。

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