FDA 510(k)

ManaSport

K号: K210284 · 2022-04-26

决定日期2022-04-26

产品代码IMI

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决定实质等同

器械摘要

ManaSport is the device name listed in this FDA 510(k) record. The listed applicant is Manamed, Inc.. It received FDA 510(k) clearance on 2022-04-26 under 510(k) number K210284. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ManaSport?

ManaSport is a medical device that received FDA 510(k) clearance on 2022-04-26. The listed applicant is Manamed, Inc.. The 510(k) number is K210284.

When did ManaSport receive FDA 510(k) clearance?

ManaSport received FDA 510(k) clearance on 2022-04-26, under 510(k) number K210284.

Who is the listed applicant for ManaSport?

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

What is the FDA product code for ManaSport?

The FDA product code for ManaSport is IMI.

列明Manamed, Inc.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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