FDA 510(k)

GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)

K号: K253102 · 2026-06-04

决定日期2026-06-04

产品代码SAH

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决定实质等同

器械摘要

GT Metabolic MagDI System (MAG-01, 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 2026-06-04 under 510(k) number K253102. 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 GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)?

GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is Gt Metabolic Solutions, Inc.. The 510(k) number is K253102.

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

GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) received FDA 510(k) clearance on 2026-06-04, under 510(k) number K253102.

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

The FDA product code for GT Metabolic MagDI System (MAG-01, 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）K243359MagDI系统（MAG-02, DS-01）K242086MagDI系统（MAG-01, DS-01）

官方来源

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