FDA 510(k)

CUBEScan BioCon-1100

K号: K201995 · 2020-08-19

决定日期2020-08-19

产品代码IYO

咨询委员会RA

决定实质等同

器械摘要

CUBEScan BioCon-1100 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 2020-08-19 under 510(k) number K201995. 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-1100?

CUBEScan BioCon-1100 is a medical device that received FDA 510(k) clearance on 2020-08-19. The listed applicant is Mcube Technology Co., Ltd.. The 510(k) number is K201995.

When did CUBEScan BioCon-1100 receive FDA 510(k) clearance?

CUBEScan BioCon-1100 received FDA 510(k) clearance on 2020-08-19, under 510(k) number K201995.

Who is the listed applicant for CUBEScan BioCon-1100?

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-1100?

The FDA product code for CUBEScan BioCon-1100 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。

K200749CUBEScan BioCon-900S K200548CUBEScan BioCon-1100 K171591CUBEScan™ BioCon-900（膀胱容积测量系统）

官方来源

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