FDA 510(k)

CBit系列数字彩色多普勒超声系统

K号: K180974 · 2018-08-17

申请人CHISON Medical Technologies Co., Ltd.

决定日期2018-08-17

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

CBit Series Digital Color Doppler Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is CHISON Medical Technologies Co., Ltd.. It received FDA 510(k) clearance on 2018-08-17 under 510(k) number K180974. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CBit Series Digital Color Doppler Ultrasound System?

CBit Series Digital Color Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2018-08-17. The listed applicant is CHISON Medical Technologies Co., Ltd.. The 510(k) number is K180974.

When did CBit Series Digital Color Doppler Ultrasound System receive FDA 510(k) clearance?

CBit Series Digital Color Doppler Ultrasound System received FDA 510(k) clearance on 2018-08-17, under 510(k) number K180974.

Who is the listed applicant for CBit Series Digital Color Doppler Ultrasound System?

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

What is the FDA product code for CBit Series Digital Color Doppler Ultrasound System?

The FDA product code for CBit Series Digital Color Doppler Ultrasound System is IYN.

列明CHISON Medical Technologies 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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相关器械（代码：IYN）

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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