FDA 510(k)

Klockner套件

K号: K243128 · 2024-12-18

决定日期2024-12-18

产品代码KCT

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Klockner Kits is the device name listed in this FDA 510(k) record. The listed applicant is SOADCO, S.L.. It received FDA 510(k) clearance on 2024-12-18 under 510(k) number K243128. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Klockner Kits?

Klockner Kits is a medical device that received FDA 510(k) clearance on 2024-12-18. The listed applicant is SOADCO, S.L.. The 510(k) number is K243128.

When did Klockner Kits receive FDA 510(k) clearance?

Klockner Kits received FDA 510(k) clearance on 2024-12-18, under 510(k) number K243128.

Who is the listed applicant for Klockner Kits?

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

What is the FDA product code for Klockner Kits?

The FDA product code for Klockner Kits is KCT.

列明SOADCO, S.L.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。

K230103Klockner牙槽 K173642KLOCKNER 外科箱 K170022Klockner Vega TiBase for CEREC K153098KLOCKNER VEGA 牙科植入系统 K151194KLOCKNER 牙科植入体基座（II）

官方来源

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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。