FDA 510(k)

어제렉스

K-번호: K231514 · 2024-02-14

결정일2024-02-14

제품 코드GEX

자문 위원회SU

결정Substantially Equivalent

기기 요약

Azure is the device name listed in this FDA 510(k) record. The listed applicant is Daeshin Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2024-02-14 under 510(k) number K231514. 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 Azure?

Azure is a medical device that received FDA 510(k) clearance on 2024-02-14. The listed applicant is Daeshin Enterprise Co., Ltd.. The 510(k) number is K231514.

When did Azure receive FDA 510(k) clearance?

Azure received FDA 510(k) clearance on 2024-02-14, under 510(k) number K231514.

Who is the listed applicant for Azure?

The FDA 510(k) record lists Daeshin Enterprise Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Azure?

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

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어제렉스

기기 요약

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관련 임상시험

관련 기기 (코드: GEX)

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