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FDA 510(k)

乳腺体积导航仪(BVN)型号G-2000

K号: K211098 · 2021-05-26

决定日期2021-05-26
产品代码IYO
咨询委员会RA
决定实质等同

器械摘要

Breast Volume Navigator (BVN) Model G-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Metritrack, Inc.. It received FDA 510(k) clearance on 2021-05-26 under 510(k) number K211098. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Breast Volume Navigator (BVN) Model G-2000?

Breast Volume Navigator (BVN) Model G-2000 is a medical device that received FDA 510(k) clearance on 2021-05-26. The listed applicant is Metritrack, Inc.. The 510(k) number is K211098.

When did Breast Volume Navigator (BVN) Model G-2000 receive FDA 510(k) clearance?

Breast Volume Navigator (BVN) Model G-2000 received FDA 510(k) clearance on 2021-05-26, under 510(k) number K211098.

Who is the listed applicant for Breast Volume Navigator (BVN) Model G-2000?

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

What is the FDA product code for Breast Volume Navigator (BVN) Model G-2000?

The FDA product code for Breast Volume Navigator (BVN) Model G-2000 is IYO.

相关临床试验

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相关器械(代码:IYO)

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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