Genteel 穿刺設備
K 號：K153670 · 2016-05-12
廣告
器材摘要
Genteel Lancing Device is the device name listed in this FDA 510(k) record. The listed applicant is Genteel, LLC. It received FDA 510(k) clearance on 2016-05-12 under 510(k) number K153670. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Genteel Lancing Device?
Genteel Lancing Device is a medical device that received FDA 510(k) clearance on 2016-05-12. The listed applicant is Genteel, LLC. The 510(k) number is K153670.
When did Genteel Lancing Device receive FDA 510(k) clearance?
Genteel Lancing Device received FDA 510(k) clearance on 2016-05-12, under 510(k) number K153670.
Who is the listed applicant for Genteel Lancing Device?
The FDA 510(k) record lists Genteel, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Genteel Lancing Device?
The FDA product code for Genteel Lancing Device is FMK.
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：FMK）
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。
K262526安全針 (XL)Tianjin Huahong Technology Co., Ltd.K261045驗精安全針Promisemed Hangzhou Meditech Co., Ltd.K260191安全針刺器（XXXVII）Tianjin Huahong Technology Co., Ltd.K253605安全針刺針Ningbo Medsun Medical Co., Ltd.K252490足跟針安全針筒（HHZ-II，HHZ-III，HHZ-IV）Tianjin Huahong Technology Co., Ltd.K251694安全針Tianjin Huahong Technology Co., Ltd.
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