FDA 510(k)

Pentax 医疗阀门套装

K号: K222980 · 2022-11-21

申请人Yangzhou Fartley Medical Instrument Technology Co., Ltd.

决定日期2022-11-21

产品代码ODC

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决定实质等同

器械摘要

Pentax Medical Valve Set is the device name listed in this FDA 510(k) record. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-21 under 510(k) number K222980. 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 Pentax Medical Valve Set?

Pentax Medical Valve Set is a medical device that received FDA 510(k) clearance on 2022-11-21. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. The 510(k) number is K222980.

When did Pentax Medical Valve Set receive FDA 510(k) clearance?

Pentax Medical Valve Set received FDA 510(k) clearance on 2022-11-21, under 510(k) number K222980.

Who is the listed applicant for Pentax Medical Valve Set?

FDA 510(k)记录将扬州法尔莱医疗器械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 Pentax Medical Valve Set?

The FDA product code for Pentax Medical Valve Set is ODC.

列明Yangzhou Fartley Medical Instrument 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。

K260512一次性输尿管通道鞘 K260423一次性内镜远端附件 K250732一次性内窥镜阀门套装 K230004一次性止血夹 K220785Clean Connecting Tube K220292一次性内镜注射针

查看所有 9 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。