ORskin Blue
K号: K232858 · 2024-05-01
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器械摘要
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.
常见问题
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.
相关临床试验
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相关器械（代码：GEX）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
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