FDA 510(k)

DEKA TORO

K 號：K240752 · 2024-05-16

決定日期2024-05-16

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 TORO 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 2024-05-16 under 510(k) number K240752. 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 TORO?

DEKA TORO is a medical device that received FDA 510(k) clearance on 2024-05-16. The listed applicant is El.En S.P.A.. The 510(k) number is K240752.

When did DEKA TORO receive FDA 510(k) clearance?

DEKA TORO received FDA 510(k) clearance on 2024-05-16, under 510(k) number K240752.

Who is the listed applicant for DEKA TORO?

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 TORO?

The FDA product code for DEKA TORO 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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