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FDA 510(k)

膀胱扫描仪型号:BVT02

K号: K223448 · 2023-07-07

决定日期2023-07-07
产品代码IYO
咨询委员会RA
决定实质等同

器械摘要

Bladder Scanner Model: BVT02 is the device name listed in this FDA 510(k) record. The listed applicant is Xuzhou Kaixin Electronic Instrument Co., Ltd.. It received FDA 510(k) clearance on 2023-07-07 under 510(k) number K223448. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Bladder Scanner Model: BVT02?

Bladder Scanner Model: BVT02 is a medical device that received FDA 510(k) clearance on 2023-07-07. The listed applicant is Xuzhou Kaixin Electronic Instrument Co., Ltd.. The 510(k) number is K223448.

When did Bladder Scanner Model: BVT02 receive FDA 510(k) clearance?

Bladder Scanner Model: BVT02 received FDA 510(k) clearance on 2023-07-07, under 510(k) number K223448.

Who is the listed applicant for Bladder Scanner Model: BVT02?

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

What is the FDA product code for Bladder Scanner Model: BVT02?

The FDA product code for Bladder Scanner Model: BVT02 is IYO.

相关临床试验

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。

相关器械(代码:IYO)

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。

官方来源

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