FDA 510(k)

一次性阀门套装

K号: K192258 · 2019-12-30

申请人Zhejiang Chuangxiang Medical Technology Co., Ltd.

决定日期2019-12-30

产品代码ODC

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决定实质等同

器械摘要

Disposable Valve Sets is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-12-30 under 510(k) number K192258. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Valve Sets?

Disposable Valve Sets is a medical device that received FDA 510(k) clearance on 2019-12-30. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. The 510(k) number is K192258.

When did Disposable Valve Sets receive FDA 510(k) clearance?

Disposable Valve Sets received FDA 510(k) clearance on 2019-12-30, under 510(k) number K192258.

Who is the listed applicant for Disposable Valve Sets?

FDA 510(k)记录将浙江创想医疗科技有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Disposable Valve Sets?

The FDA product code for Disposable Valve Sets is ODC.

列明Zhejiang Chuangxiang Medical 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。

K260410单次使用输尿管通道鞘 K253132一次性结石取出球囊 K251890一次性输尿管支架 K230773内镜冲洗管 K231471空气/水瓶软管，CO2 源软管 K220063一次性细胞刷

查看所有 14 个设备 →

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。