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FDA 510(k)

Tasso+

K号: K221131 · 2022-08-12

申请人Tasso, Inc.
决定日期2022-08-12
产品代码FMK
咨询委员会SU 请注意,您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Tasso+ is the device name listed in this FDA 510(k) record. The listed applicant is Tasso, Inc.. It received FDA 510(k) clearance on 2022-08-12 under 510(k) number K221131. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tasso+?

Tasso+ is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is Tasso, Inc.. The 510(k) number is K221131.

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

Tasso+ received FDA 510(k) clearance on 2022-08-12, under 510(k) number K221131.

Who is the listed applicant for Tasso+?

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

What is the FDA product code for Tasso+?

The FDA product code for Tasso+ is FMK.

相关临床试验

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相关器械(代码:FMK)

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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