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FDA 510(k)

MeMed BV

K号: K230944 · 2023-06-30

决定日期2023-06-30
产品代码QPS
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决定实质等同

器械摘要

MeMed BV is the device name listed in this FDA 510(k) record. The listed applicant is MeMed Diagnostics, Ltd.. It received FDA 510(k) clearance on 2023-06-30 under 510(k) number K230944. The device is classified under product code QPS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MeMed BV?

MeMed BV is a medical device that received FDA 510(k) clearance on 2023-06-30. The listed applicant is MeMed Diagnostics, Ltd.. The 510(k) number is K230944.

When did MeMed BV receive FDA 510(k) clearance?

MeMed BV received FDA 510(k) clearance on 2023-06-30, under 510(k) number K230944.

Who is the listed applicant for MeMed BV?

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

What is the FDA product code for MeMed BV?

The FDA product code for MeMed BV is QPS.

相关临床试验

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列明MeMed Diagnostics, Ltd.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:QPS)

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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