FDA 510(k)

Arisure 闭式安瓿适配器

K号: K172884 · 2017-10-03

决定日期2017-10-03

产品代码LHI

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

Arisure Closed Vial Adapter is the device name listed in this FDA 510(k) record. The listed applicant is Yukon Medical. It received FDA 510(k) clearance on 2017-10-03 under 510(k) number K172884. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Arisure Closed Vial Adapter?

Arisure Closed Vial Adapter is a medical device that received FDA 510(k) clearance on 2017-10-03. The listed applicant is Yukon Medical. The 510(k) number is K172884.

When did Arisure Closed Vial Adapter receive FDA 510(k) clearance?

Arisure Closed Vial Adapter received FDA 510(k) clearance on 2017-10-03, under 510(k) number K172884.

Who is the listed applicant for Arisure Closed Vial Adapter?

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

What is the FDA product code for Arisure Closed Vial Adapter?

The FDA product code for Arisure Closed Vial Adapter is LHI.

列明Yukon Medical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。

K172631Arisure 干刺 K171101Closed Male Luer

相关器械（代码：LHI）

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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