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FDA 510(k)

Supria True64

K号: K171738 · 2017-08-18

决定日期2017-08-18
产品代码JAK
咨询委员会RA
决定实质等同

器械摘要

Supria True64 is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Healthcare Americas Corporation. It received FDA 510(k) clearance on 2017-08-18 under 510(k) number K171738. 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 Supria True64?

Supria True64 is a medical device that received FDA 510(k) clearance on 2017-08-18. The listed applicant is Hitachi Healthcare Americas Corporation. The 510(k) number is K171738.

When did Supria True64 receive FDA 510(k) clearance?

Supria True64 received FDA 510(k) clearance on 2017-08-18, under 510(k) number K171738.

Who is the listed applicant for Supria True64?

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

What is the FDA product code for Supria True64?

The FDA product code for Supria True64 is JAK.

相关临床试验

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列明Hitachi Healthcare Americas Corporation为申报人的其他记录

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相关器械(代码:JAK)

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官方来源

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