FDA 510(k)

多单元DAS系统

K号: K231559 · 2023-11-17

决定日期2023-11-17

产品代码NHA

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决定实质等同

器械摘要

Multi-Unit DAS System is the device name listed in this FDA 510(k) record. The listed applicant is Talladium España, SL. It received FDA 510(k) clearance on 2023-11-17 under 510(k) number K231559. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Multi-Unit DAS System?

Multi-Unit DAS System is a medical device that received FDA 510(k) clearance on 2023-11-17. The listed applicant is Talladium España, SL. The 510(k) number is K231559.

When did Multi-Unit DAS System receive FDA 510(k) clearance?

Multi-Unit DAS System received FDA 510(k) clearance on 2023-11-17, under 510(k) number K231559.

Who is the listed applicant for Multi-Unit DAS System?

The FDA 510(k) record lists Talladium España, SL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Multi-Unit DAS System?

The FDA product code for Multi-Unit DAS System is NHA.

列明Talladium España, SL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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相关器械（代码：NHA）

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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