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FDA 510(k)

iLet® ACE 泵

K 號：K231485 · 2023-06-21

申請人Beta Bionics, Inc.
決定日期2023-06-21
產品代碼QFG
諮詢委員會CH
決定相當於

器材摘要

iLet® ACE Pump 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 2023-06-21 under 510(k) number K231485. The device is classified under product code QFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iLet® ACE Pump?

iLet® ACE Pump is a medical device that received FDA 510(k) clearance on 2023-06-21. The listed applicant is Beta Bionics, Inc.. The 510(k) number is K231485.

When did iLet® ACE Pump receive FDA 510(k) clearance?

iLet® ACE Pump received FDA 510(k) clearance on 2023-06-21, under 510(k) number K231485.

Who is the listed applicant for iLet® ACE Pump?

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® ACE Pump?

The FDA product code for iLet® ACE Pump is QFG.

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。

K262763iLet 計劃劑量決策軟體K260001薄荷ACE泵K253976iLet ACE 泵K252770iLet ACE 泵K232224iLet® 藥物劑量決策軟體K220916iLet® 藥物劑量決策軟體

查看所有 8 項裝置 →

相關器械（代碼：QFG）

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Beta Bionics, Inc.K261672twiist自動胰島素輸送（AID）系統Deka Research and DevelopmentK253976iLet ACE 泵Beta Bionics, Inc.K253743迷你美德Flex泵Medtronic Minimed, Inc.K253470MiniMed 780G 胰島素針筒 (MMT-1884)；MiniMed 780G 胰島素針筒組合包 (MMT-1894)Medtronic Minimed, Inc.K253074Tandem Mobi 胰島素針筒配互操作性技術Tandem Diabetes Care, Inc.

官方來源

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