FDA 510(k)

OneTouch Via 即時針對性胰島素輸送系統

K 號：K163357 · 2017-06-07

申請人Lifescan Europe, A Division of Cilag GmbH

決定日期2017-06-07

產品代碼OPP

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

OneTouch Via On-Demand Insulin Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Lifescan Europe, A Division of Cilag GmbH. It received FDA 510(k) clearance on 2017-06-07 under 510(k) number K163357. The device is classified under product code OPP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OneTouch Via On-Demand Insulin Delivery System?

OneTouch Via On-Demand Insulin Delivery System is a medical device that received FDA 510(k) clearance on 2017-06-07. The listed applicant is Lifescan Europe, A Division of Cilag GmbH. The 510(k) number is K163357.

When did OneTouch Via On-Demand Insulin Delivery System receive FDA 510(k) clearance?

OneTouch Via On-Demand Insulin Delivery System received FDA 510(k) clearance on 2017-06-07, under 510(k) number K163357.

Who is the listed applicant for OneTouch Via On-Demand Insulin Delivery System?

The FDA 510(k) record lists Lifescan Europe, A Division of Cilag GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OneTouch Via On-Demand Insulin Delivery System?

The FDA product code for OneTouch Via On-Demand Insulin Delivery System is OPP.

相關器械（代碼：OPP）

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K252757CeQur Simplicity™ 即時釋放胰島素輸送系統Cequr SA K243273CeQur Simplicity™ 即時釋放胰島素輸送系統Cequr SA K233447CeQur Simplicity™ 即時釋放胰島素輸送系統Cequr SA

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：OPP）

官方來源