FDA 510(k)

VS3-铱系统（VS3-IR）

K号: K223020 · 2022-10-28

决定日期2022-10-28

产品代码OWN

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决定实质等同

器械摘要

VS3-Iridium System (VS3-IR) is the device name listed in this FDA 510(k) record. The listed applicant is Visionsense, Ltd.. It received FDA 510(k) clearance on 2022-10-28 under 510(k) number K223020. 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 System (VS3-IR)?

VS3-Iridium System (VS3-IR) is a medical device that received FDA 510(k) clearance on 2022-10-28. The listed applicant is Visionsense, Ltd.. The 510(k) number is K223020.

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

VS3-Iridium System (VS3-IR) received FDA 510(k) clearance on 2022-10-28, under 510(k) number K223020.

Who is the listed applicant for VS3-Iridium System (VS3-IR)?

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 System (VS3-IR)?

The FDA product code for VS3-Iridium System (VS3-IR) 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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