FDA 510(k)

UF(II)宽型装置

K号: K173975 · 2018-06-01

决定日期2018-06-01

产品代码DZE

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决定实质等同

器械摘要

UF(II) Wide Fixture is the device name listed in this FDA 510(k) record. The listed applicant is Dio Corporation. It received FDA 510(k) clearance on 2018-06-01 under 510(k) number K173975. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the UF(II) Wide Fixture?

UF(II) Wide Fixture is a medical device that received FDA 510(k) clearance on 2018-06-01. The listed applicant is Dio Corporation. The 510(k) number is K173975.

When did UF(II) Wide Fixture receive FDA 510(k) clearance?

UF(II) Wide Fixture received FDA 510(k) clearance on 2018-06-01, under 510(k) number K173975.

Who is the listed applicant for UF(II) Wide Fixture?

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

What is the FDA product code for UF(II) Wide Fixture?

The FDA product code for UF(II) Wide Fixture is DZE.

列明Dio 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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官方来源

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