FDA 510(k)

Infinity-Lock 3, Infinity-Lock 5

K号: K171680 · 2017-06-30

决定日期2017-06-30

产品代码GAT

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决定实质等同

器械摘要

Infinity-Lock 3, Infinity-Lock 5 is the device name listed in this FDA 510(k) record. The listed applicant is Xiros, Ltd.. It received FDA 510(k) clearance on 2017-06-30 under 510(k) number K171680. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Infinity-Lock 3, Infinity-Lock 5?

Infinity-Lock 3, Infinity-Lock 5 is a medical device that received FDA 510(k) clearance on 2017-06-30. The listed applicant is Xiros, Ltd.. The 510(k) number is K171680.

When did Infinity-Lock 3, Infinity-Lock 5 receive FDA 510(k) clearance?

Infinity-Lock 3, Infinity-Lock 5 received FDA 510(k) clearance on 2017-06-30, under 510(k) number K171680.

Who is the listed applicant for Infinity-Lock 3, Infinity-Lock 5?

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

What is the FDA product code for Infinity-Lock 3, Infinity-Lock 5?

The FDA product code for Infinity-Lock 3, Infinity-Lock 5 is GAT.

列明Xiros, Ltd.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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