FDA 510(k)

智能調節技術

K 號：K203774 · 2022-01-27

決定日期2022-01-27

產品代碼QJI

諮詢委員會CH

決定相當於

器材摘要

SmartAdjust technology is the device name listed in this FDA 510(k) record. The listed applicant is Insulet Corporation. It received FDA 510(k) clearance on 2022-01-27 under 510(k) number K203774. 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 SmartAdjust technology?

SmartAdjust technology is a medical device that received FDA 510(k) clearance on 2022-01-27. The listed applicant is Insulet Corporation. The 510(k) number is K203774.

When did SmartAdjust technology receive FDA 510(k) clearance?

SmartAdjust technology received FDA 510(k) clearance on 2022-01-27, under 510(k) number K203774.

Who is the listed applicant for SmartAdjust technology?

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 SmartAdjust technology?

The FDA product code for SmartAdjust technology 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 K251779Omnipod 5 適配演算法 K241777SmartAdjust™ 技術 K232741SmartAdjust(TM) 技術 K231824智慧輸注計算器 K231826Omnipod 5 ACE 泵

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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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