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FDA 510(k)

VS3-红外

K号: K191851 · 2019-11-25

申请人Medtronic
决定日期2019-11-25
产品代码OWN
咨询委员会GU 请注意,由于您只提供了“GU”这个词,我无法提供完整的翻译。如果您能提供完整的句子或段落,我将能够为您提供准确的翻译。
决定实质等同

器械摘要

VS3-IR is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2019-11-25 under 510(k) number K191851. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VS3-IR?

VS3-IR is a medical device that received FDA 510(k) clearance on 2019-11-25. The listed applicant is Medtronic. The 510(k) number is K191851.

When did VS3-IR receive FDA 510(k) clearance?

VS3-IR received FDA 510(k) clearance on 2019-11-25, under 510(k) number K191851.

Who is the listed applicant for VS3-IR?

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

What is the FDA product code for VS3-IR?

The FDA product code for VS3-IR is OWN.

列明Medtronic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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相关器械(代码:OWN)

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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数据来源于FDA开放API。如需最新且权威的信息,请务必参考官方记录。

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