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FDA 510(k)

EmbryoSlide+ ic8 dish

K号: K213869 · 2022-03-11

申请人Vitrolife A/S
决定日期2022-03-11
产品代码MQK
咨询委员会OB 请注意,由于您没有提供具体的医疗设备监管文本,我无法进行翻译。请提供具体的文本内容,以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

EmbryoSlide+ ic8 dish is the device name listed in this FDA 510(k) record. The listed applicant is Vitrolife A/S. It received FDA 510(k) clearance on 2022-03-11 under 510(k) number K213869. 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 EmbryoSlide+ ic8 dish?

EmbryoSlide+ ic8 dish is a medical device that received FDA 510(k) clearance on 2022-03-11. The listed applicant is Vitrolife A/S. The 510(k) number is K213869.

When did EmbryoSlide+ ic8 dish receive FDA 510(k) clearance?

EmbryoSlide+ ic8 dish received FDA 510(k) clearance on 2022-03-11, under 510(k) number K213869.

Who is the listed applicant for EmbryoSlide+ ic8 dish?

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

What is the FDA product code for EmbryoSlide+ ic8 dish?

The FDA product code for EmbryoSlide+ ic8 dish is MQK.

相关临床试验

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。

列明Vitrolife 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。

相关器械(代码:MQK)

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。

官方来源

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