FDA 510(k)

CeQur Simplicity™ 即時釋放胰島素輸送系統

K 號：K252757 · 2026-04-10

決定日期2026-04-10

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

CeQur Simplicity™ On-Demand Insulin Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Cequr SA. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K252757. 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 CeQur Simplicity™ On-Demand Insulin Delivery System?

CeQur Simplicity™ On-Demand Insulin Delivery System is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Cequr SA. The 510(k) number is K252757.

When did CeQur Simplicity™ On-Demand Insulin Delivery System receive FDA 510(k) clearance?

CeQur Simplicity™ On-Demand Insulin Delivery System received FDA 510(k) clearance on 2026-04-10, under 510(k) number K252757.

Who is the listed applicant for CeQur Simplicity™ On-Demand Insulin Delivery System?

The FDA 510(k) record lists Cequr SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CeQur Simplicity™ On-Demand Insulin Delivery System?

The FDA product code for CeQur Simplicity™ On-Demand Insulin Delivery System is OPP.

其他以 Cequr SA 為申請人之記錄

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。

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

相關器械（代碼：OPP）

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。

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 K163357OneTouch Via 即時針對性胰島素輸送系統Lifescan Europe, A Division of Cilag GmbH

官方來源

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