FDA 510(k)

BM.IRIS

K-번호: K171648 · 2017-09-08

결정일2017-09-08

제품 코드GEX

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

결정대체적으로 동일

기기 요약

BM.IRIS is the device name listed in this FDA 510(k) record. The listed applicant is Bluecore Co., Ltd.. It received FDA 510(k) clearance on 2017-09-08 under 510(k) number K171648. 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 BM.IRIS?

BM.IRIS is a medical device that received FDA 510(k) clearance on 2017-09-08. The listed applicant is Bluecore Co., Ltd.. The 510(k) number is K171648.

When did BM.IRIS receive FDA 510(k) clearance?

BM.IRIS received FDA 510(k) clearance on 2017-09-08, under 510(k) number K171648.

Who is the listed applicant for BM.IRIS?

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

What is the FDA product code for BM.IRIS?

The FDA product code for BM.IRIS 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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