FDA 510(k)

Multi M Series

K号: K250826 · 2025-06-12

决定日期2025-06-12

产品代码EIH

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决定实质等同

器械摘要

Multi M Series is the device name listed in this FDA 510(k) record. The listed applicant is Dmax Co., Ltd.. It received FDA 510(k) clearance on 2025-06-12 under 510(k) number K250826. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Multi M Series?

Multi M Series is a medical device that received FDA 510(k) clearance on 2025-06-12. The listed applicant is Dmax Co., Ltd.. The 510(k) number is K250826.

When did Multi M Series receive FDA 510(k) clearance?

Multi M Series received FDA 510(k) clearance on 2025-06-12, under 510(k) number K250826.

Who is the listed applicant for Multi M Series?

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

What is the FDA product code for Multi M Series?

The FDA product code for Multi M Series is EIH.

列明Dmax Co., Ltd.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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