FDA 510(k)

ManaSport+

K号: K222098 · 2023-03-08

决定日期2023-03-08

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 2023-03-08 under 510(k) number K222098. 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 2023-03-08. The listed applicant is Manamed, Inc.. The 510(k) number is K222098.

When did ManaSport+ receive FDA 510(k) clearance?

ManaSport+ received FDA 510(k) clearance on 2023-03-08, under 510(k) number K222098.

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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