FDA 510(k)

ORION

K-번호: K161503 · 2016-08-26

결정일2016-08-26

제품 코드GEX

자문 위원회SU

결정Substantially Equivalent

기기 요약

ORION is the device name listed in this FDA 510(k) record. The listed applicant is Yerim Engineering Co., Ltd.. It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K161503. 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 ORION?

ORION is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Yerim Engineering Co., Ltd.. The 510(k) number is K161503.

When did ORION receive FDA 510(k) clearance?

ORION received FDA 510(k) clearance on 2016-08-26, under 510(k) number K161503.

Who is the listed applicant for ORION?

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

What is the FDA product code for ORION?

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

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ORION

기기 요약

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관련 임상시험

관련 기기 (코드: GEX)

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