FDA 510(k)

MagDI系统（MAG-02, DS-01）

K号: K243359 · 2025-02-28

决定日期2025-02-28

产品代码SAH

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

MagDI System (MAG-02, DS-01) is the device name listed in this FDA 510(k) record. The listed applicant is Gt Metabolic Solutions, Inc.. It received FDA 510(k) clearance on 2025-02-28 under 510(k) number K243359. The device is classified under product code SAH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MagDI System (MAG-02, DS-01)?

MagDI System (MAG-02, DS-01) is a medical device that received FDA 510(k) clearance on 2025-02-28. The listed applicant is Gt Metabolic Solutions, Inc.. The 510(k) number is K243359.

When did MagDI System (MAG-02, DS-01) receive FDA 510(k) clearance?

MagDI System (MAG-02, DS-01) received FDA 510(k) clearance on 2025-02-28, under 510(k) number K243359.

Who is the listed applicant for MagDI System (MAG-02, DS-01)?

FDA 510(k)记录将Gt Metabolic Solutions, Inc.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for MagDI System (MAG-02, DS-01)?

The FDA product code for MagDI System (MAG-02, DS-01) is SAH.

列明Gt Metabolic Solutions, 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。

K261467GT 代谢磁系统（MAG-04，DS-01）（MAG-05，DS-01）K253102GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)K242086MagDI系统（MAG-01, DS-01）

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。