Insignis® 注射器输液系统
K号: K232328 · 2024-03-01
广告
决定日期2024-03-01
产品代码FPA
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
Insignis™ Syringe Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health Sciences, LLC. It received FDA 510(k) clearance on 2024-03-01 under 510(k) number K232328. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Insignis™ Syringe Infusion System?
Insignis™ Syringe Infusion System is a medical device that received FDA 510(k) clearance on 2024-03-01. The listed applicant is Innovative Health Sciences, LLC. The 510(k) number is K232328.
When did Insignis™ Syringe Infusion System receive FDA 510(k) clearance?
Insignis™ Syringe Infusion System received FDA 510(k) clearance on 2024-03-01, under 510(k) number K232328.
Who is the listed applicant for Insignis™ Syringe Infusion System?
The FDA 510(k) record lists Innovative Health Sciences, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Insignis™ Syringe Infusion System?
The FDA product code for Insignis™ Syringe Infusion System is FPA.
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Innovative Health Sciences, LLC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：FPA）
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。
K254123Ecomed 一次性给药套装Ecomed Solutions, LLCK261530iiSure 静脉输液器Deka Research and DevelopmentK252543AMSafe 注射器套装（BA-70075，BA-70071-D，BA-70070，BA-70071-P，BA-70072，BA-70072-F，BA-70071-DF，BA-70071-DF-120，FE01，FE04）Amsino International, Inc.K251375PuraCath Firefly 无针连接器 IT (9005)Puracath Medical, Inc.K251257nSet+ 稳定装置 [6426733]; nSet+ 稳定装置带 nSyte 无针连接器 (NFC) [6426731]; nSyte 无针连接器 (NFC) [6426727]Np MedicalK250325BD Alaris 泵输液套装Carefusion (Bd)
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。
广告