FDA 510(k)

IntraMarX 不透射线标记物

K号: K191087 · 2019-12-18

决定日期2019-12-18

产品代码FFX

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决定实质等同

器械摘要

IntraMarX Radiopaque Markers is the device name listed in this FDA 510(k) record. The listed applicant is Anx Robotica Corp. It received FDA 510(k) clearance on 2019-12-18 under 510(k) number K191087. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IntraMarX Radiopaque Markers?

IntraMarX Radiopaque Markers is a medical device that received FDA 510(k) clearance on 2019-12-18. The listed applicant is Anx Robotica Corp. The 510(k) number is K191087.

When did IntraMarX Radiopaque Markers receive FDA 510(k) clearance?

IntraMarX Radiopaque Markers received FDA 510(k) clearance on 2019-12-18, under 510(k) number K191087.

Who is the listed applicant for IntraMarX Radiopaque Markers?

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

What is the FDA product code for IntraMarX Radiopaque Markers?

The FDA product code for IntraMarX Radiopaque Markers is FFX.

列明Anx Robotica Corp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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