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FDA 510(k)

Omnipod® 胰島素管理系統，Omnipod DASH® 胰島素管理系統

K 號：K211575 · 2021-08-13

申請人Insulet Corporation
決定日期2021-08-13
產品代碼LZG
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

Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System is the device name listed in this FDA 510(k) record. The listed applicant is Insulet Corporation. It received FDA 510(k) clearance on 2021-08-13 under 510(k) number K211575. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System?

Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System is a medical device that received FDA 510(k) clearance on 2021-08-13. The listed applicant is Insulet Corporation. The 510(k) number is K211575.

When did Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System receive FDA 510(k) clearance?

Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System received FDA 510(k) clearance on 2021-08-13, under 510(k) number K211575.

Who is the listed applicant for Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System?

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

What is the FDA product code for Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System?

The FDA product code for Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System is LZG.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Insulet Corporation 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。

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相關器械（代碼：LZG）

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。

K262153Pivot 胰島素輸送系統Modular Medical, Inc.K253534Pivot 胰島素輸送系統Modular MedicalK240158模組化醫療 MODD1 胰島素輸送系統Modular Medical, Inc.K241622延長式儲液器；迷你美德儲液器Medtronic MinimedK223372Omnipod GO 胰島素輸送裝置Insulet CorporationK210714延長式儲存器Medtronic Minimed, Inc.

官方來源

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