FDA 510(k)

NaviCam Xpress Stomach System, NaviCam Xpress System

K号: K230694 · 2023-04-13

决定日期2023-04-13

产品代码QKZ

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决定实质等同

器械摘要

NaviCam Xpress Stomach System, NaviCam Xpress System 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 2023-04-13 under 510(k) number K230694. The device is classified under product code QKZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NaviCam Xpress Stomach System, NaviCam Xpress System?

NaviCam Xpress Stomach System, NaviCam Xpress System is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Anx Robotica Corp. The 510(k) number is K230694.

When did NaviCam Xpress Stomach System, NaviCam Xpress System receive FDA 510(k) clearance?

NaviCam Xpress Stomach System, NaviCam Xpress System received FDA 510(k) clearance on 2023-04-13, under 510(k) number K230694.

Who is the listed applicant for NaviCam Xpress Stomach System, NaviCam Xpress System?

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 NaviCam Xpress Stomach System, NaviCam Xpress System?

The FDA product code for NaviCam Xpress Stomach System, NaviCam Xpress System is QKZ.

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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相关器械（代码：QKZ）

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。

官方来源

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