ISP安全赫伯針輸液套組
K 號：K170881 · 2017-12-14
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決定日期2017-12-14
產品代碼PTI
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
ISP Safety Huber Needle Infusion Set is the device name listed in this FDA 510(k) record. The listed applicant is Infusion Safety Products, Inc.. It received FDA 510(k) clearance on 2017-12-14 under 510(k) number K170881. The device is classified under product code PTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ISP Safety Huber Needle Infusion Set?
ISP Safety Huber Needle Infusion Set is a medical device that received FDA 510(k) clearance on 2017-12-14. The listed applicant is Infusion Safety Products, Inc.. The 510(k) number is K170881.
When did ISP Safety Huber Needle Infusion Set receive FDA 510(k) clearance?
ISP Safety Huber Needle Infusion Set received FDA 510(k) clearance on 2017-12-14, under 510(k) number K170881.
Who is the listed applicant for ISP Safety Huber Needle Infusion Set?
The FDA 510(k) record lists Infusion Safety Products, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ISP Safety Huber Needle Infusion Set?
The FDA product code for ISP Safety Huber Needle Infusion Set is PTI.
相關臨床試驗
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相關器械（代碼：PTI）
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。
K25409525G 胡伯針Martech Medical ProductsK252355K-SHIELD Advantage PORT ACCESS 灌注設備 高壓管路Sb-Kawasumi Laboratories, Inc.K251138Promisemed 安全中心 Huber 靈敏針Promisemed Hangzhou Meditech Co., Ltd.K243332Promisemed 安全中心 Huber 靈敏針Promisemed Hangzhou Meditech Co., Ltd.K241353PowerLoc™ Max 電漿注射輸液套組；SafeStep™ Huber 鋒針套組Bard Access Systems, Inc.K230715Promisemed 安全中心 Huber 针Promisemed Hangzhou Meditech 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。
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