FDA 510(k)

NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether

K号: K233229 · 2024-01-05

决定日期2024-01-05

产品代码NEZ

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether is the device name listed in this FDA 510(k) record. The listed applicant is Anx Robotica Corporation. It received FDA 510(k) clearance on 2024-01-05 under 510(k) number K233229. The device is classified under product code NEZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether?

NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether is a medical device that received FDA 510(k) clearance on 2024-01-05. The listed applicant is Anx Robotica Corporation. The 510(k) number is K233229.

When did NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether receive FDA 510(k) clearance?

NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether received FDA 510(k) clearance on 2024-01-05, under 510(k) number K233229.

Who is the listed applicant for NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether?

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

What is the FDA product code for NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether?

The FDA product code for NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether is NEZ.

列明Anx Robotica 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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