FDA 510(k)

Omnipod 5 適配演算法

K 號：K251779 · 2025-12-03

決定日期2025-12-03

產品代碼QJI

諮詢委員會CH

決定相當於

器材摘要

Omnipod 5 algorithm is the device name listed in this FDA 510(k) record. The listed applicant is Insulet Corporation. It received FDA 510(k) clearance on 2025-12-03 under 510(k) number K251779. The device is classified under product code QJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Omnipod 5 algorithm?

Omnipod 5 algorithm is a medical device that received FDA 510(k) clearance on 2025-12-03. The listed applicant is Insulet Corporation. The 510(k) number is K251779.

When did Omnipod 5 algorithm receive FDA 510(k) clearance?

Omnipod 5 algorithm received FDA 510(k) clearance on 2025-12-03, under 510(k) number K251779.

Who is the listed applicant for Omnipod 5 algorithm?

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 5 algorithm?

The FDA product code for Omnipod 5 algorithm is QJI.

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。

K261461Omnipod 6 適配演算法 K241777SmartAdjust™ 技術 K232741SmartAdjust(TM) 技術 K231824智慧輸注計算器 K231826Omnipod 5 ACE 泵 K223372Omnipod GO 胰島素輸送裝置

查看所有 19 項裝置 →

相關器械（代碼：QJI）

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。

K261896iOS CamAPS FXCamDiab K262763iLet 計劃劑量決策軟體Beta Bionics, Inc.K261962智能守護技術；預測性低血糖技術Medtronic MiniMed K261461Omnipod 6 適配演算法Insulet Corporation K260429控制-IQ+技術Tandem Diabetes Care, Inc.K253701智能守護技術；預測性低血糖技術Medtronic Minimed

官方來源

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