FDA 510(k)

一次性注射针

K号: K210917 · 2021-05-28

决定日期2021-05-28

产品代码FBK

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决定实质等同

器械摘要

Single Use Injection Needle is the device name listed in this FDA 510(k) record. The listed applicant is Anrei Medical (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2021-05-28 under 510(k) number K210917. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Single Use Injection Needle?

Single Use Injection Needle is a medical device that received FDA 510(k) clearance on 2021-05-28. The listed applicant is Anrei Medical (Hangzhou) Co., Ltd.. The 510(k) number is K210917.

When did Single Use Injection Needle receive FDA 510(k) clearance?

Single Use Injection Needle received FDA 510(k) clearance on 2021-05-28, under 510(k) number K210917.

Who is the listed applicant for Single Use Injection Needle?

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

What is the FDA product code for Single Use Injection Needle?

The FDA product code for Single Use Injection Needle is FBK.

列明Anrei Medical (Hangzhou) 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。

K212999多功能电外科刀 K202987Rescue 肺部抓握镊子 K210660结石取出球囊导管 K201771单次使用可旋转和可重新定位的血液夹 K192048一次性内窥镜阀门套装

相关器械（代码：FBK）

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。

官方来源

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