FDA 510(k)

Easyscreen

K号: K171506 · 2017-08-29

决定日期2017-08-29

产品代码EWO

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决定实质等同

器械摘要

Easyscreen is the device name listed in this FDA 510(k) record. The listed applicant is Maico Diagnostics GmbH. It received FDA 510(k) clearance on 2017-08-29 under 510(k) number K171506. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Easyscreen?

Easyscreen is a medical device that received FDA 510(k) clearance on 2017-08-29. The listed applicant is Maico Diagnostics GmbH. The 510(k) number is K171506.

When did Easyscreen receive FDA 510(k) clearance?

Easyscreen received FDA 510(k) clearance on 2017-08-29, under 510(k) number K171506.

Who is the listed applicant for Easyscreen?

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

What is the FDA product code for Easyscreen?

The FDA product code for Easyscreen is EWO.

列明Maico Diagnostics GmbH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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官方来源

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