FDA 510(k)

DEKA HELIX

K 號：K222221 · 2023-01-04

決定日期2023-01-04

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 HELIX is the device name listed in this FDA 510(k) record. The listed applicant is El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2023-01-04 under 510(k) number K222221. 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 HELIX?

DEKA HELIX is a medical device that received FDA 510(k) clearance on 2023-01-04. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K222221.

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

DEKA HELIX received FDA 510(k) clearance on 2023-01-04, under 510(k) number K222221.

Who is the listed applicant for DEKA HELIX?

The FDA 510(k) record lists El.En Electronic Engineering Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEKA HELIX?

The FDA product code for DEKA HELIX is GEX. This falls under the Gastroenterology category.

其他以 El.En Electronic Engineering Spa 為申請人之記錄

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