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FDA 510(k)

Psoria-Shield AURORA

K号: K192411 · 2020-07-02

申请人Psoria-Shield
决定日期2020-07-02
产品代码FTC
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Psoria-Shield AURORA is the device name listed in this FDA 510(k) record. The listed applicant is Psoria-Shield. It received FDA 510(k) clearance on 2020-07-02 under 510(k) number K192411. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Psoria-Shield AURORA?

Psoria-Shield AURORA is a medical device that received FDA 510(k) clearance on 2020-07-02. The listed applicant is Psoria-Shield. The 510(k) number is K192411.

When did Psoria-Shield AURORA receive FDA 510(k) clearance?

Psoria-Shield AURORA received FDA 510(k) clearance on 2020-07-02, under 510(k) number K192411.

Who is the listed applicant for Psoria-Shield AURORA?

The FDA 510(k) record lists Psoria-Shield as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Psoria-Shield AURORA?

The FDA product code for Psoria-Shield AURORA is FTC.

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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：FTC）

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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