FDA 510(k)

Galvanic Spa，型号：SKB-1405

K号: K163470 · 2017-06-02

申请人Shenzhen Siken 3D Technology Development Co., Ltd.

决定日期2017-06-02

产品代码NFO

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Galvanic Spa, Model: SKB-1405 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Siken 3D Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2017-06-02 under 510(k) number K163470. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Galvanic Spa, Model: SKB-1405?

Galvanic Spa, Model: SKB-1405 is a medical device that received FDA 510(k) clearance on 2017-06-02. The listed applicant is Shenzhen Siken 3D Technology Development Co., Ltd.. The 510(k) number is K163470.

When did Galvanic Spa, Model: SKB-1405 receive FDA 510(k) clearance?

Galvanic Spa, Model: SKB-1405 received FDA 510(k) clearance on 2017-06-02, under 510(k) number K163470.

Who is the listed applicant for Galvanic Spa, Model: SKB-1405?

The FDA 510(k) record lists Shenzhen Siken 3D Technology Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Galvanic Spa, Model: SKB-1405?

The FDA product code for Galvanic Spa, Model: SKB-1405 is NFO.

列明Shenzhen Siken 3D Technology Development 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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