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FDA 510(k)

Servator B SALF溶液

K号: K180481 · 2018-06-29

申请人S.A.L.F. Spa
决定日期2018-06-29
产品代码KDN
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

Servator B SALF Solution is the device name listed in this FDA 510(k) record. The listed applicant is S.A.L.F. Spa. It received FDA 510(k) clearance on 2018-06-29 under 510(k) number K180481. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Servator B SALF Solution?

Servator B SALF Solution is a medical device that received FDA 510(k) clearance on 2018-06-29. The listed applicant is S.A.L.F. Spa. The 510(k) number is K180481.

When did Servator B SALF Solution receive FDA 510(k) clearance?

Servator B SALF Solution received FDA 510(k) clearance on 2018-06-29, under 510(k) number K180481.

Who is the listed applicant for Servator B SALF Solution?

The FDA 510(k) record lists S.A.L.F. Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Servator B SALF Solution?

The FDA product code for Servator B SALF Solution is KDN.

相关临床试验

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。

列明S.A.L.F. Spa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。

相关器械(代码:KDN)

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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