FDA 510(k)

维瓦托姆普罗

K号: K233775 · 2024-02-22

决定日期2024-02-22

产品代码MXA

咨询委员会TX 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

Vivatmo pro is the device name listed in this FDA 510(k) record. The listed applicant is Bosch Healthcare Solutions GmbH. It received FDA 510(k) clearance on 2024-02-22 under 510(k) number K233775. The device is classified under product code MXA. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vivatmo pro?

Vivatmo pro is a medical device that received FDA 510(k) clearance on 2024-02-22. The listed applicant is Bosch Healthcare Solutions GmbH. The 510(k) number is K233775.

When did Vivatmo pro receive FDA 510(k) clearance?

Vivatmo pro received FDA 510(k) clearance on 2024-02-22, under 510(k) number K233775.

Who is the listed applicant for Vivatmo pro?

The FDA 510(k) record lists Bosch Healthcare Solutions GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vivatmo pro?

The FDA product code for Vivatmo pro is MXA.

列明Bosch Healthcare Solutions GmbH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。

K243926Vivatmo pro-S

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。