FDA 510(k)

Serafin®

K号: K232074 · 2024-02-22

决定日期2024-02-22

产品代码NXC

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决定实质等同

器械摘要

Serafin® is the device name listed in this FDA 510(k) record. The listed applicant is Tns Co., Ltd.. It received FDA 510(k) clearance on 2024-02-22 under 510(k) number K232074. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Serafin®?

Serafin® is a medical device that received FDA 510(k) clearance on 2024-02-22. The listed applicant is Tns Co., Ltd.. The 510(k) number is K232074.

When did Serafin® receive FDA 510(k) clearance?

Serafin® received FDA 510(k) clearance on 2024-02-22, under 510(k) number K232074.

Who is the listed applicant for Serafin®?

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

What is the FDA product code for Serafin®?

The FDA product code for Serafin® is NXC.

列明Tns 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。

K251758Serafin®

官方来源

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