MedtFine 靈敏血液針
K 號：K221383 · 2022-09-21
廣告
決定日期2022-09-21
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
MedtFine Blood Lancet is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Carelife International Trading Co. , Ltd.. It received FDA 510(k) clearance on 2022-09-21 under 510(k) number K221383. 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 MedtFine Blood Lancet?
MedtFine Blood Lancet is a medical device that received FDA 510(k) clearance on 2022-09-21. The listed applicant is Shanghai Carelife International Trading Co. , Ltd.. The 510(k) number is K221383.
When did MedtFine Blood Lancet receive FDA 510(k) clearance?
MedtFine Blood Lancet received FDA 510(k) clearance on 2022-09-21, under 510(k) number K221383.
Who is the listed applicant for MedtFine Blood Lancet?
The FDA 510(k) record lists Shanghai Carelife International Trading Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MedtFine Blood Lancet?
The FDA product code for MedtFine Blood Lancet is QRK.
相關臨床試驗
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。
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.AK244031一次性血針（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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
廣告