FDA 510(k)

LOCATOR F-Tx 连接系统

K号: K151789 · 2016-03-04

决定日期2016-03-04

产品代码NHA

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决定实质等同

器械摘要

LOCATOR F-Tx Attachment System is the device name listed in this FDA 510(k) record. The listed applicant is Zest Anchors, LLC. It received FDA 510(k) clearance on 2016-03-04 under 510(k) number K151789. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LOCATOR F-Tx Attachment System?

LOCATOR F-Tx Attachment System is a medical device that received FDA 510(k) clearance on 2016-03-04. The listed applicant is Zest Anchors, LLC. The 510(k) number is K151789.

When did LOCATOR F-Tx Attachment System receive FDA 510(k) clearance?

LOCATOR F-Tx Attachment System received FDA 510(k) clearance on 2016-03-04, under 510(k) number K151789.

Who is the listed applicant for LOCATOR F-Tx Attachment System?

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

What is the FDA product code for LOCATOR F-Tx Attachment System?

The FDA product code for LOCATOR F-Tx Attachment System is NHA.

列明Zest Anchors, LLC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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相关器械（代码：NHA）

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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