FDA 510(k)

ZenPro 40

K号: K230268 · 2023-08-10

决定日期2023-08-10

产品代码GEX

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决定实质等同

器械摘要

ZenPro 40 is the device name listed in this FDA 510(k) record. The listed applicant is BLUECORE COMPANY Co., Ltd.. It received FDA 510(k) clearance on 2023-08-10 under 510(k) number K230268. 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 ZenPro 40?

ZenPro 40 is a medical device that received FDA 510(k) clearance on 2023-08-10. The listed applicant is BLUECORE COMPANY Co., Ltd.. The 510(k) number is K230268.

When did ZenPro 40 receive FDA 510(k) clearance?

ZenPro 40 received FDA 510(k) clearance on 2023-08-10, under 510(k) number K230268.

Who is the listed applicant for ZenPro 40?

FDA 510(k)记录将BLUECORE COMPANY Co., Ltd.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for ZenPro 40?

The FDA product code for ZenPro 40 is GEX. This falls under the Gastroenterology category.

列明BLUECORE COMPANY Co., Ltd.为申报人的其他记录

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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