FDA 510(k)

스카르 3

K-번호: K231309 · 2023-06-02

결정일2023-06-02

제품 코드GEX

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

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.

자주 묻는 질문

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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기기 요약

자주 묻는 질문

관련 기기 (코드: GEX)

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