FDA 510(k)

Freestyle Mini 无线

K号: K253510 · 2026-04-10

决定日期2026-04-10

产品代码HGX

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决定实质等同

器械摘要

Freestyle Mini Hands-free is the device name listed in this FDA 510(k) record. The listed applicant is Medela, LLC. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K253510. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Freestyle Mini Hands-free?

Freestyle Mini Hands-free is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Medela, LLC. The 510(k) number is K253510.

When did Freestyle Mini Hands-free receive FDA 510(k) clearance?

Freestyle Mini Hands-free received FDA 510(k) clearance on 2026-04-10, under 510(k) number K253510.

Who is the listed applicant for Freestyle Mini Hands-free?

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

What is the FDA product code for Freestyle Mini Hands-free?

The FDA product code for Freestyle Mini Hands-free is HGX.

列明Medela, LLC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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相关器械（代码：HGX）

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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