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FDA 510(k)

Accuvue+

K号: K201058 · 2020-05-06

申请人Radmedix, LLC
决定日期2020-05-06
产品代码MQB
咨询委员会RA
决定实质等同

器械摘要

Accuvue+ is the device name listed in this FDA 510(k) record. The listed applicant is Radmedix, LLC. It received FDA 510(k) clearance on 2020-05-06 under 510(k) number K201058. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Accuvue+?

Accuvue+ is a medical device that received FDA 510(k) clearance on 2020-05-06. The listed applicant is Radmedix, LLC. The 510(k) number is K201058.

When did Accuvue+ receive FDA 510(k) clearance?

Accuvue+ received FDA 510(k) clearance on 2020-05-06, under 510(k) number K201058.

Who is the listed applicant for Accuvue+?

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

What is the FDA product code for Accuvue+?

The FDA product code for Accuvue+ is MQB.

相关临床试验

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列明Radmedix, LLC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。

相关器械(代码:MQB)

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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