FDA 510(k)

VACUETTE SAFELINK 套管式连接器

K号: K180545 · 2018-05-21

决定日期2018-05-21

产品代码FMI

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

VACUETTE SAFELINK Holder with male luer lock is the device name listed in this FDA 510(k) record. The listed applicant is Greiner Bio-One Na, Inc.. It received FDA 510(k) clearance on 2018-05-21 under 510(k) number K180545. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VACUETTE SAFELINK Holder with male luer lock?

VACUETTE SAFELINK Holder with male luer lock is a medical device that received FDA 510(k) clearance on 2018-05-21. The listed applicant is Greiner Bio-One Na, Inc.. The 510(k) number is K180545.

When did VACUETTE SAFELINK Holder with male luer lock receive FDA 510(k) clearance?

VACUETTE SAFELINK Holder with male luer lock received FDA 510(k) clearance on 2018-05-21, under 510(k) number K180545.

Who is the listed applicant for VACUETTE SAFELINK Holder with male luer lock?

The FDA 510(k) record lists Greiner Bio-One Na, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VACUETTE SAFELINK Holder with male luer lock?

The FDA product code for VACUETTE SAFELINK Holder with male luer lock is FMI.

列明Greiner Bio-One Na, 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：FMI）

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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