iLet® ACE 泵
K号: K231485 · 2023-06-21
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决定日期2023-06-21
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 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.
常见问题
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)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 DevelopmentK253976iLet ACE 泵Beta Bionics, Inc.K253743MiniMed 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.
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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