FDA 510(k)

ENFit 连接器

K号: K233190 · 2024-01-18

决定日期2024-01-18

产品代码PIO

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决定实质等同

器械摘要

ENFit Adaptor is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Caina Medical Co.,Ltd. It received FDA 510(k) clearance on 2024-01-18 under 510(k) number K233190. The device is classified under product code PIO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ENFit Adaptor?

ENFit Adaptor is a medical device that received FDA 510(k) clearance on 2024-01-18. The listed applicant is Jiangsu Caina Medical Co.,Ltd. The 510(k) number is K233190.

When did ENFit Adaptor receive FDA 510(k) clearance?

ENFit Adaptor received FDA 510(k) clearance on 2024-01-18, under 510(k) number K233190.

Who is the listed applicant for ENFit Adaptor?

The FDA 510(k) record lists Jiangsu Caina Medical Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENFit Adaptor?

The FDA product code for ENFit Adaptor is PIO.

列明Jiangsu Caina Medical Co.,Ltd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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