FDA 510(k)

德卡藍光束

K 號：K243683 · 2025-06-12

決定日期2025-06-12

產品代碼GEX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Deka Bluebeam is the device name listed in this FDA 510(k) record. The listed applicant is El.En S.P.A.. It received FDA 510(k) clearance on 2025-06-12 under 510(k) number K243683. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Deka Bluebeam?

Deka Bluebeam is a medical device that received FDA 510(k) clearance on 2025-06-12. The listed applicant is El.En S.P.A.. The 510(k) number is K243683.

When did Deka Bluebeam receive FDA 510(k) clearance?

Deka Bluebeam received FDA 510(k) clearance on 2025-06-12, under 510(k) number K243683.

Who is the listed applicant for Deka Bluebeam?

The FDA 510(k) record lists El.En S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Deka Bluebeam?

The FDA product code for Deka Bluebeam is GEX. This falls under the Gastroenterology category.

其他以 El.En S.P.A. 為申請人之記錄

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