Omnipod 5 ACE 泵 (Pod)
K号: K203768 · 2022-01-27
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决定日期2022-01-27
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
Omnipod 5 ACE Pump (Pod) is the device name listed in this FDA 510(k) record. The listed applicant is Insulet Corporation. It received FDA 510(k) clearance on 2022-01-27 under 510(k) number K203768. 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 Omnipod 5 ACE Pump (Pod)?
Omnipod 5 ACE Pump (Pod) is a medical device that received FDA 510(k) clearance on 2022-01-27. The listed applicant is Insulet Corporation. The 510(k) number is K203768.
When did Omnipod 5 ACE Pump (Pod) receive FDA 510(k) clearance?
Omnipod 5 ACE Pump (Pod) received FDA 510(k) clearance on 2022-01-27, under 510(k) number K203768.
Who is the listed applicant for Omnipod 5 ACE Pump (Pod)?
The FDA 510(k) record lists Insulet Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Omnipod 5 ACE Pump (Pod)?
The FDA product code for Omnipod 5 ACE Pump (Pod) 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Insulet Corporation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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