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FDA 510(k)

CADD® Infusion Disposables Portfolio with NRFit™ connectors

K号: K162219 · 2017-07-20

决定日期2017-07-20
产品代码PWH
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

CADD® Infusion Disposables Portfolio with NRFit™ connectors 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 2017-07-20 under 510(k) number K162219. The device is classified under product code PWH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CADD® Infusion Disposables Portfolio with NRFit™ connectors?

CADD® Infusion Disposables Portfolio with NRFit™ connectors is a medical device that received FDA 510(k) clearance on 2017-07-20. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K162219.

When did CADD® Infusion Disposables Portfolio with NRFit™ connectors receive FDA 510(k) clearance?

CADD® Infusion Disposables Portfolio with NRFit™ connectors received FDA 510(k) clearance on 2017-07-20, under 510(k) number K162219.

Who is the listed applicant for CADD® Infusion Disposables Portfolio with NRFit™ connectors?

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 CADD® Infusion Disposables Portfolio with NRFit™ connectors?

The FDA product code for CADD® Infusion Disposables Portfolio with NRFit™ connectors is PWH.

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。

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相关器械(代码:PWH)

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。

官方来源

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