FDA 510(k)

ORskin 블루

K-번호: K232858 · 2024-05-01

결정일2024-05-01

제품 코드GEX

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

결정대체적으로 동일

기기 요약

ORskin Blue is the device name listed in this FDA 510(k) record. The listed applicant is Megabay S.A.. It received FDA 510(k) clearance on 2024-05-01 under 510(k) number K232858. 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 ORskin Blue?

ORskin Blue is a medical device that received FDA 510(k) clearance on 2024-05-01. The listed applicant is Megabay S.A.. The 510(k) number is K232858.

When did ORskin Blue receive FDA 510(k) clearance?

ORskin Blue received FDA 510(k) clearance on 2024-05-01, under 510(k) number K232858.

Who is the listed applicant for ORskin Blue?

The FDA 510(k) record lists Megabay S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORskin Blue?

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

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ORskin 블루

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: GEX)

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