FDA 510(k)

一滴針刺設備

K 號：K223815 · 2023-02-15

決定日期2023-02-15

產品代碼QRK

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Stat Medical Devices 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K230310STAT醫療設備針刺系統 K222617EasyTouch 穿刺器

相關器械（代碼：QRK）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262631一次性血液針刺器（Soft Pro、Softsure、Softsure Pro、Softsense）SteriLance Medical (Suzhou), Inc.K261634一次性血針（柔軟）SteriLance Medical (Suzhou), Inc.K250016droplet®個人式針刺器Htl-Strefa S.A K244031一次性血針（柔軟Pro）；一次性血針（柔穩Pro）；一次性血針（柔穩Pro）；一次性血針（柔感）SteriLance Medical (Suzhou), Inc.K242622單次使用无菌針頭刺針Ningbo Caremed Medical Products Co., Ltd.K241810MICROLET®NEXT 刺針Ascensia Diabetes Care U.S., Inc.

官方來源

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