FDA 510(k)

ONE DROP Lancing Device

K号: K223815 · 2023-02-15

决定日期2023-02-15

产品代码QRK

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决定实质等同

器械摘要

ONE DROP Lancing Device is the device name listed in this FDA 510(k) record. The listed applicant is Stat Medical Devices. It received FDA 510(k) clearance on 2023-02-15 under 510(k) number K223815. 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 ONE DROP Lancing Device?

ONE DROP Lancing Device is a medical device that received FDA 510(k) clearance on 2023-02-15. The listed applicant is Stat Medical Devices. The 510(k) number is K223815.

When did ONE DROP Lancing Device receive FDA 510(k) clearance?

ONE DROP Lancing Device received FDA 510(k) clearance on 2023-02-15, under 510(k) number K223815.

Who is the listed applicant for ONE DROP Lancing Device?

The FDA 510(k) record lists Stat Medical Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONE DROP Lancing Device?

The FDA product code for ONE DROP Lancing Device is QRK.

列明Stat Medical Devices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。

K230310STAT Medical Device Lancing System K222617EasyTouch 刺针装置

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。

K262631一次性血刺针（Soft Pro，Softsure，Softsure Pro，Softsense）SteriLance Medical (Suzhou), Inc.K261634一次性血刺针（软）SteriLance Medical (Suzhou), Inc.K250016droplet®个人采血针Htl-Strefa S.A K244031一次性血刺针（软Pro）；一次性血刺针（Softsure）；一次性血刺针（Softsure Pro）；一次性血刺针（Softsense）SteriLance Medical (Suzhou), Inc.K242622一次性无菌 lancetsNingbo Caremed Medical Products Co., Ltd.K241810MICROLET®NEXT 刺针Ascensia Diabetes Care U.S., Inc.

官方来源

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