FDA 510(k)

腔内给药套装，带旋塞和歧管

K号: K223175 · 2023-03-10

决定日期2023-03-10

产品代码FMG

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

lntravascular Administration Sets with Stopcock and Manifold is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2023-03-10 under 510(k) number K223175. The device is classified under product code FMG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the lntravascular Administration Sets with Stopcock and Manifold?

lntravascular Administration Sets with Stopcock and Manifold is a medical device that received FDA 510(k) clearance on 2023-03-10. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K223175.

When did lntravascular Administration Sets with Stopcock and Manifold receive FDA 510(k) clearance?

lntravascular Administration Sets with Stopcock and Manifold received FDA 510(k) clearance on 2023-03-10, under 510(k) number K223175.

Who is the listed applicant for lntravascular Administration Sets with Stopcock and Manifold?

The FDA 510(k) record lists Baxter Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for lntravascular Administration Sets with Stopcock and Manifold?

The FDA product code for lntravascular Administration Sets with Stopcock and Manifold is FMG.

列明Baxter Healthcare 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。

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官方来源

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