FDA 510(k)

iLet® 藥物劑量決策軟體

K 號：K232224 · 2023-09-22

決定日期2023-09-22

產品代碼QJI

諮詢委員會CH

決定相當於

器材摘要

iLet® Dosing Decision Software is the device name listed in this FDA 510(k) record. The listed applicant is Beta Bionics, Inc.. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K232224. 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 iLet® Dosing Decision Software?

iLet® Dosing Decision Software is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Beta Bionics, Inc.. The 510(k) number is K232224.

When did iLet® Dosing Decision Software receive FDA 510(k) clearance?

iLet® Dosing Decision Software received FDA 510(k) clearance on 2023-09-22, under 510(k) number K232224.

Who is the listed applicant for iLet® Dosing Decision Software?

FDA 510(k) 記錄將 Beta Bionics, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for iLet® Dosing Decision Software?

The FDA product code for iLet® Dosing Decision Software is QJI.

其他以 Beta Bionics, Inc. 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。

K260001薄荷ACE泵 K262763iLet 計劃劑量決策軟體 K253976iLet ACE 泵 K252770iLet ACE 泵 K231485iLet® ACE 泵 K223846iLet® 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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