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FDA 510(k)

iLet ACE 泵

K 號：K253976 · 2026-04-30

申請人Beta Bionics, Inc.
決定日期2026-04-30
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 2026-04-30 under 510(k) number K253976. 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 2026-04-30. The listed applicant is Beta Bionics, Inc.. The 510(k) number is K253976.

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

iLet ACE Pump received FDA 510(k) clearance on 2026-04-30, under 510(k) number K253976.

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K252770iLet ACE 泵K232224iLet® 藥物劑量決策軟體K231485iLet® ACE 泵K223846iLet® ACE 泵

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 DevelopmentK253743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.K252770iLet ACE 泵Beta Bionics, Inc.

官方來源

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