FDA 510(k)

Pathfinder® CR 系统

K号: K240853 · 2024-06-27

决定日期2024-06-27

产品代码FED

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Unknown

器械摘要

Pathfinder® CR System is the device name listed in this FDA 510(k) record. The listed applicant is Neptune Medical, Inc.. It received FDA 510(k) clearance on 2024-06-27 under 510(k) number K240853. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常见问题

What is the Pathfinder® CR System?

Pathfinder® CR System is a medical device that received FDA 510(k) clearance on 2024-06-27. The listed applicant is Neptune Medical, Inc.. The 510(k) number is K240853.

When did Pathfinder® CR System receive FDA 510(k) clearance?

Pathfinder® CR System received FDA 510(k) clearance on 2024-06-27, under 510(k) number K240853.

Who is the listed applicant for Pathfinder® CR System?

FDA 510(k)记录中列出了Neptune Medical, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Pathfinder® CR System?

The FDA product code for Pathfinder® CR System is FED.

列明Neptune Medical, Inc.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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。