TrueCare Biomedix 防拆標記蓋子
K 號：K210818 · 2021-09-15
廣告
決定日期2021-09-15
產品代碼FMF
諮詢委員會醫療設備規範文本翻譯如下：
HO
注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於
器材摘要
TrueCare Biomedix Tamper Evident Cap is the device name listed in this FDA 510(k) record. The listed applicant is Us Infusion Inc. D/B/A Truecare Biomedix-USA. It received FDA 510(k) clearance on 2021-09-15 under 510(k) number K210818. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the TrueCare Biomedix Tamper Evident Cap?
TrueCare Biomedix Tamper Evident Cap is a medical device that received FDA 510(k) clearance on 2021-09-15. The listed applicant is Us Infusion Inc. D/B/A Truecare Biomedix-USA. The 510(k) number is K210818.
When did TrueCare Biomedix Tamper Evident Cap receive FDA 510(k) clearance?
TrueCare Biomedix Tamper Evident Cap received FDA 510(k) clearance on 2021-09-15, under 510(k) number K210818.
Who is the listed applicant for TrueCare Biomedix Tamper Evident Cap?
The FDA 510(k) record lists Us Infusion Inc. D/B/A Truecare Biomedix-USA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TrueCare Biomedix Tamper Evident Cap?
The FDA product code for TrueCare Biomedix Tamper Evident Cap is FMF.
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：FMF）
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。
K262581GraftGun 適用性移植輸送系統 (GDS®)SurGenTec, LLCK252184SOL-M 輪狀釋放針筒配可交換針盤Sol-Millennium Medical, Inc.K253747一次性針筒注射器（KXYC-03C02，KXYC-03A03）Jiangsu Enjosim Medical Technology Co., Ltd.K260208超細™ 安全胰島素針embecta Medical II, LLCK253110溶滑安全針；溶滑安全針搭配針筒Sol-Millennium Medical, Inc.K260514Profoject™ 安全針；Profoject™ 配有安全針的注射器；Profoject™ 低死腔配有安全針的注射器CMT Health PTE., 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