FDA 510(k)

Intellifuse给药和Intellifuse血液给药套装

K号: K192375 · 2020-09-18

决定日期2020-09-18

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

Intellifuse Administration and Intellifuse Blood Administration Sets is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2020-09-18 under 510(k) number K192375. 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 Intellifuse Administration and Intellifuse Blood Administration Sets?

Intellifuse Administration and Intellifuse Blood Administration Sets is a medical device that received FDA 510(k) clearance on 2020-09-18. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K192375.

When did Intellifuse Administration and Intellifuse Blood Administration Sets receive FDA 510(k) clearance?

Intellifuse Administration and Intellifuse Blood Administration Sets received FDA 510(k) clearance on 2020-09-18, under 510(k) number K192375.

Who is the listed applicant for Intellifuse Administration and Intellifuse Blood Administration Sets?

The FDA 510(k) record lists Smiths Medical Asd, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intellifuse Administration and Intellifuse Blood Administration Sets?

The FDA product code for Intellifuse Administration and Intellifuse Blood Administration Sets is FPA.

列明Smiths Medical Asd, 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。

K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe K210833Portex BLUxl 长型气管切开管，BLUxl 吸痰辅助长型气管切开管，BLUxl 长型气管切开管内芯 K211634Hypodermic Needle-Pro EDGE Safety Device K181699Level 1对流加热器 K172800Portex® Lancet Point 脊髓穿刺针带NRFit®连接器，Portex® Pencil Point 脊髓穿刺针带NRFit®连接器 K172823Portex NRFit 蛛网膜下腔穿刺针

查看所有 16 个设备 →

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, LLC K261530iiSure 静脉输液器Deka Research and Development K252543AMSafe 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 Medical K250325BD Alaris 泵输液套装Carefusion (Bd)

官方来源

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