FDA 510(k)

MiniMed Go 应用

K号: K253512 · 2026-01-08

决定日期2026-01-08

产品代码NDC

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决定实质等同

器械摘要

MiniMed Go App is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Minimed. It received FDA 510(k) clearance on 2026-01-08 under 510(k) number K253512. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MiniMed Go App?

MiniMed Go App is a medical device that received FDA 510(k) clearance on 2026-01-08. The listed applicant is Medtronic Minimed. The 510(k) number is K253512.

When did MiniMed Go App receive FDA 510(k) clearance?

MiniMed Go App received FDA 510(k) clearance on 2026-01-08, under 510(k) number K253512.

Who is the listed applicant for MiniMed Go App?

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

What is the FDA product code for MiniMed Go App?

The FDA product code for MiniMed Go App is NDC.

列明Medtronic Minimed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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