FDA 510(k)

VS3 铱系统

K号: K210265 · 2021-11-22

决定日期2021-11-22

产品代码OWN

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决定实质等同

器械摘要

VS3 Iridium Sytem is the device name listed in this FDA 510(k) record. The listed applicant is Visionsense, Ltd.. It received FDA 510(k) clearance on 2021-11-22 under 510(k) number K210265. 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 Iridium Sytem?

VS3 Iridium Sytem is a medical device that received FDA 510(k) clearance on 2021-11-22. The listed applicant is Visionsense, Ltd.. The 510(k) number is K210265.

When did VS3 Iridium Sytem receive FDA 510(k) clearance?

VS3 Iridium Sytem received FDA 510(k) clearance on 2021-11-22, under 510(k) number K210265.

Who is the listed applicant for VS3 Iridium Sytem?

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

What is the FDA product code for VS3 Iridium Sytem?

The FDA product code for VS3 Iridium Sytem is OWN.

列明Visionsense, 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。

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官方来源

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