FDA 510(k)

EQUIA LC ONE

K号: K250953 · 2025-09-19

决定日期2025-09-19

产品代码EMA

咨询委员会DE 请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。

决定实质等同

器械摘要

EQUIA LC ONE is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K250953. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EQUIA LC ONE?

EQUIA LC ONE is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is GC America, Inc.. The 510(k) number is K250953.

When did EQUIA LC ONE receive FDA 510(k) clearance?

EQUIA LC ONE received FDA 510(k) clearance on 2025-09-19, under 510(k) number K250953.

Who is the listed applicant for EQUIA LC ONE?

FDA 510(k)记录中列出GC America, Inc.为申请人。这本身并不足以确立该设备的制造商。

What is the FDA product code for EQUIA LC ONE?

The FDA product code for EQUIA LC ONE is EMA.

列明GC America, 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。

K262202Cerasmart Forte K253317Cytrans® Elashield K261246SRGC-06 K254109G-CEM UNIVERSAL K251124G-Bond通用 K251946G aenial通用注射剂II

查看所有 25 个设备 →

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。