FDA 510(k)

一次性血刺针

K号: K223314 · 2023-01-25

申请人Huaian Hening Medical Instruments Co., Ltd.

决定日期2023-01-25

产品代码QRK

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决定实质等同

器械摘要

Disposable Blood Lancets is the device name listed in this FDA 510(k) record. The listed applicant is Huaian Hening Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2023-01-25 under 510(k) number K223314. The device is classified under product code QRK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Blood Lancets?

Disposable Blood Lancets is a medical device that received FDA 510(k) clearance on 2023-01-25. The listed applicant is Huaian Hening Medical Instruments Co., Ltd.. The 510(k) number is K223314.

When did Disposable Blood Lancets receive FDA 510(k) clearance?

Disposable Blood Lancets received FDA 510(k) clearance on 2023-01-25, under 510(k) number K223314.

Who is the listed applicant for Disposable Blood Lancets?

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

What is the FDA product code for Disposable Blood Lancets?

The FDA product code for Disposable Blood Lancets is QRK.

列明Huaian Hening Medical Instruments 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。

K223313一次性安全注射针

相关器械（代码：QRK）

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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