FDA 510(k)

SCAR 3

K 號：K231309 · 2023-06-02

決定日期2023-06-02

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

SCAR 3 is the device name listed in this FDA 510(k) record. The listed applicant is El.En Electroinc Engineering Spa. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K231309. 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 SCAR 3?

SCAR 3 is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is El.En Electroinc Engineering Spa. The 510(k) number is K231309.

When did SCAR 3 receive FDA 510(k) clearance?

SCAR 3 received FDA 510(k) clearance on 2023-06-02, under 510(k) number K231309.

Who is the listed applicant for SCAR 3?

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

What is the FDA product code for SCAR 3?

The FDA product code for SCAR 3 is GEX. This falls under the Gastroenterology category.

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