FDA 510(k)

ConceptoMed Luer-Jack Slip 10ml

K号: K162057 · 2017-01-11

决定日期2017-01-11

产品代码FMF

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

ConceptoMed Luer-Jack Slip 10ml is the device name listed in this FDA 510(k) record. The listed applicant is Conceptomed AS. It received FDA 510(k) clearance on 2017-01-11 under 510(k) number K162057. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ConceptoMed Luer-Jack Slip 10ml?

ConceptoMed Luer-Jack Slip 10ml is a medical device that received FDA 510(k) clearance on 2017-01-11. The listed applicant is Conceptomed AS. The 510(k) number is K162057.

When did ConceptoMed Luer-Jack Slip 10ml receive FDA 510(k) clearance?

ConceptoMed Luer-Jack Slip 10ml received FDA 510(k) clearance on 2017-01-11, under 510(k) number K162057.

Who is the listed applicant for ConceptoMed Luer-Jack Slip 10ml?

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

What is the FDA product code for ConceptoMed Luer-Jack Slip 10ml?

The FDA product code for ConceptoMed Luer-Jack Slip 10ml is FMF.

列明Conceptomed AS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。

K1718053 ml Luer-Jack Slip，5 ml Luer-Jack Slip，20 ml Luer-Jack Slip，10 ml Luer-Jack Lock

相关器械（代码：FMF）

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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