FDA 510(k)

G-CEM UNIVERSAL

K号: K254109 · 2026-05-18

决定日期2026-05-18

产品代码EMA

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决定实质等同

器械摘要

G-CEM UNIVERSAL 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 2026-05-18 under 510(k) number K254109. 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 G-CEM UNIVERSAL?

G-CEM UNIVERSAL is a medical device that received FDA 510(k) clearance on 2026-05-18. The listed applicant is GC America, Inc.. The 510(k) number is K254109.

When did G-CEM UNIVERSAL receive FDA 510(k) clearance?

G-CEM UNIVERSAL received FDA 510(k) clearance on 2026-05-18, under 510(k) number K254109.

Who is the listed applicant for G-CEM UNIVERSAL?

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 G-CEM UNIVERSAL?

The FDA product code for G-CEM UNIVERSAL 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。

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