FDA 510(k)

Omnipod GO 胰島素輸送裝置

K 號：K223372 · 2023-04-24

決定日期2023-04-24

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 GO Insulin Delivery Device is the device name listed in this FDA 510(k) record. The listed applicant is Insulet Corporation. It received FDA 510(k) clearance on 2023-04-24 under 510(k) number K223372. 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 GO Insulin Delivery Device?

Omnipod GO Insulin Delivery Device is a medical device that received FDA 510(k) clearance on 2023-04-24. The listed applicant is Insulet Corporation. The 510(k) number is K223372.

When did Omnipod GO Insulin Delivery Device receive FDA 510(k) clearance?

Omnipod GO Insulin Delivery Device received FDA 510(k) clearance on 2023-04-24, under 510(k) number K223372.

Who is the listed applicant for Omnipod GO Insulin Delivery Device?

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 GO Insulin Delivery Device?

The FDA product code for Omnipod GO Insulin Delivery Device is LZG.

其他以 Insulet Corporation 為申請人之記錄

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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 Medical K240158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 Minimed K210714延長式儲存器Medtronic Minimed, Inc.K211575Omnipod® 胰島素管理系統，Omnipod DASH® 胰島素管理系統Insulet Corporation

官方來源

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