FDA 510(k)

STAT醫療設備針刺系統

K 號：K230310 · 2023-09-08

決定日期2023-09-08

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

STAT Medical Device Lancing System 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 2023-09-08 under 510(k) number K230310. 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 STAT Medical Device Lancing System?

STAT Medical Device Lancing System is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Stat Medical Devices. The 510(k) number is K230310.

When did STAT Medical Device Lancing System receive FDA 510(k) clearance?

STAT Medical Device Lancing System received FDA 510(k) clearance on 2023-09-08, under 510(k) number K230310.

Who is the listed applicant for STAT Medical Device Lancing System?

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 STAT Medical Device Lancing System?

The FDA product code for STAT Medical Device Lancing System 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。

K222617EasyTouch 穿刺器 K223815一滴針刺設備

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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