FDA 510(k)

Y-MIC

K号: K161639 · 2016-12-22

决定日期2016-12-22

产品代码ELC

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决定实质等同

器械摘要

Y-MIC is the device name listed in this FDA 510(k) record. The listed applicant is Micron Corporation. It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K161639. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Y-MIC?

Y-MIC is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Micron Corporation. The 510(k) number is K161639.

When did Y-MIC receive FDA 510(k) clearance?

Y-MIC received FDA 510(k) clearance on 2016-12-22, under 510(k) number K161639.

Who is the listed applicant for Y-MIC?

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

What is the FDA product code for Y-MIC?

The FDA product code for Y-MIC is ELC.

列明Micron Corporation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。

K171150AW-100

相关器械（代码：ELC）

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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