DEKA ACE 泵系统
K号: K213536 · 2023-07-25
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决定日期2023-07-25
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。
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器械摘要
DEKA ACE Pump System is the device name listed in this FDA 510(k) record. The listed applicant is Deka Research and Development. It received FDA 510(k) clearance on 2023-07-25 under 510(k) number K213536. 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 DEKA ACE Pump System?
DEKA ACE Pump System is a medical device that received FDA 510(k) clearance on 2023-07-25. The listed applicant is Deka Research and Development. The 510(k) number is K213536.
When did DEKA ACE Pump System receive FDA 510(k) clearance?
DEKA ACE Pump System received FDA 510(k) clearance on 2023-07-25, under 510(k) number K213536.
Who is the listed applicant for DEKA ACE Pump System?
The FDA 510(k) record lists Deka Research and Development as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DEKA ACE Pump System?
The FDA product code for DEKA ACE Pump System is QFG.
相关临床试验
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。
列明Deka Research and Development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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