iLet ACE 泵
K号: K253976 · 2026-04-30
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决定日期2026-04-30
产品代码QFG
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
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.
常见问题
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)记录中列出Beta Bionics, Inc.为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for iLet ACE Pump?
The FDA product code for iLet ACE Pump is QFG.
列明Beta Bionics, Inc.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：QFG）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K260001薄荷ACE泵Beta Bionics, Inc.K261672twiist 自动胰岛素输送（AID）系统Deka Research and DevelopmentK253743MiniMed Flex 泵Medtronic Minimed, Inc.K253470MiniMed 780G 胰岛素泵（MMT-1884）；MiniMed 780G 胰岛素泵套装（MMT-1894）Medtronic Minimed, Inc.K253074Tandem Mobi 胰岛素泵，具有互操作性技术Tandem Diabetes Care, Inc.K252770iLet ACE 泵Beta Bionics, Inc.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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