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FDA 510(k)

TaiChiB

K号: K210921 · 2021-11-02

决定日期2021-11-02
产品代码IYE
咨询委员会RA
决定实质等同

器械摘要

TaiChiB is the device name listed in this FDA 510(k) record. The listed applicant is Our United Corporation. It received FDA 510(k) clearance on 2021-11-02 under 510(k) number K210921. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TaiChiB?

TaiChiB is a medical device that received FDA 510(k) clearance on 2021-11-02. The listed applicant is Our United Corporation. The 510(k) number is K210921.

When did TaiChiB receive FDA 510(k) clearance?

TaiChiB received FDA 510(k) clearance on 2021-11-02, under 510(k) number K210921.

Who is the listed applicant for TaiChiB?

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

What is the FDA product code for TaiChiB?

The FDA product code for TaiChiB is IYE.

相关临床试验

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列明Our United Corporation为申报人的其他记录

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相关器械(代码:IYE)

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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