FDA 510(k)

Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1

K号: K170177 · 2017-06-30

决定日期2017-06-30

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) V8.3 with FIRST 2.1 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 2017-06-30 under 510(k) number K170177. 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) V8.3 with FIRST 2.1?

Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 is a medical device that received FDA 510(k) clearance on 2017-06-30. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K170177.

When did Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 receive FDA 510(k) clearance?

Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 received FDA 510(k) clearance on 2017-06-30, under 510(k) number K170177.

Who is the listed applicant for Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1?

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) V8.3 with FIRST 2.1?

The FDA product code for Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 is JAK.

列明Toshibamedical Systems Corporation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。

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