FDA 510(k)

维特里加德

K号: K180740 · 2018-05-04

决定日期2018-05-04

产品代码MQK

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决定实质等同

器械摘要

VitriGuard is the device name listed in this FDA 510(k) record. The listed applicant is Origio A/S. It received FDA 510(k) clearance on 2018-05-04 under 510(k) number K180740. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VitriGuard?

VitriGuard is a medical device that received FDA 510(k) clearance on 2018-05-04. The listed applicant is Origio A/S. The 510(k) number is K180740.

When did VitriGuard receive FDA 510(k) clearance?

VitriGuard received FDA 510(k) clearance on 2018-05-04, under 510(k) number K180740.

Who is the listed applicant for VitriGuard?

The FDA 510(k) record lists Origio A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VitriGuard?

The FDA product code for VitriGuard is MQK.

列明Origio A/S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。

K200815维特里加德 K173624ORIGIO® Handling™ 无酚红 (Cat. No. 8310), ORIGIO® Handling™ 有酚红 (Cat. No. 8311)K172197SAGE 1-Step GM-CSF with HSA，SAGE 1-Step GM-CSF with SPS K161547Transem和EchoGen胚胎移植导管 K162833维特里加德 K153267ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO 精子洗涤

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。