FDA 510(k)

G-CEM 大眾化

K 號：K254109 · 2026-05-18

決定日期2026-05-18

產品代碼EMA

諮詢委員會DE

決定相當於

器材摘要

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.

常見問題

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) 記錄將 GC America, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for G-CEM UNIVERSAL?

The FDA product code for G-CEM UNIVERSAL is EMA.

其他以 GC America, Inc. 為申請人之記錄

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相關器械（代碼：EMA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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