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FDA 510(k)

E-Guard

K号: K201173 · 2020-11-27

决定日期2020-11-27
产品代码MQC
决定实质等同

器械摘要

E-Guard is the device name listed in this FDA 510(k) record. The listed applicant is Envisiontec GmbH. It received FDA 510(k) clearance on 2020-11-27 under 510(k) number K201173. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

常见问题

What is the E-Guard?

E-Guard is a medical device that received FDA 510(k) clearance on 2020-11-27. The listed applicant is Envisiontec GmbH. The 510(k) number is K201173.

When did E-Guard receive FDA 510(k) clearance?

E-Guard received FDA 510(k) clearance on 2020-11-27, under 510(k) number K201173.

Who is the listed applicant for E-Guard?

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

What is the FDA product code for E-Guard?

The FDA product code for E-Guard is MQC.

相关临床试验

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列明Envisiontec GmbH为申报人的其他记录

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相关器械(代码:MQC)

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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