FDA 510(k)

CUBEScan™ BioCon-900（膀胱容积测量系统）

K号: K171591 · 2017-06-22

决定日期2017-06-22

产品代码IYO

咨询委员会RA

决定实质等同

器械摘要

CUBEScan™ BioCon-900 (Bladder Volume Measurement System) is the device name listed in this FDA 510(k) record. The listed applicant is Mcube Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-06-22 under 510(k) number K171591. 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 CUBEScan™ BioCon-900 (Bladder Volume Measurement System)?

CUBEScan™ BioCon-900 (Bladder Volume Measurement System) is a medical device that received FDA 510(k) clearance on 2017-06-22. The listed applicant is Mcube Technology Co., Ltd.. The 510(k) number is K171591.

When did CUBEScan™ BioCon-900 (Bladder Volume Measurement System) receive FDA 510(k) clearance?

CUBEScan™ BioCon-900 (Bladder Volume Measurement System) received FDA 510(k) clearance on 2017-06-22, under 510(k) number K171591.

Who is the listed applicant for CUBEScan™ BioCon-900 (Bladder Volume Measurement System)?

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

What is the FDA product code for CUBEScan™ BioCon-900 (Bladder Volume Measurement System)?

The FDA product code for CUBEScan™ BioCon-900 (Bladder Volume Measurement System) is IYO.

列明Mcube Technology 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。

K201995CUBEScan BioCon-1100 K200749CUBEScan BioCon-900S K200548CUBEScan BioCon-1100

官方来源

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