FDA 510(k)

EmbryoScope+

K号: K173264 · 2018-05-11

决定日期2018-05-11

产品代码MQG

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

EmbryoScope+ 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 2018-05-11 under 510(k) number K173264. The device is classified under product code MQG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EmbryoScope+?

EmbryoScope+ is a medical device that received FDA 510(k) clearance on 2018-05-11. The listed applicant is Vitrolife A/S. The 510(k) number is K173264.

When did EmbryoScope+ receive FDA 510(k) clearance?

EmbryoScope+ received FDA 510(k) clearance on 2018-05-11, under 510(k) number K173264.

Who is the listed applicant for EmbryoScope+?

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 EmbryoScope+?

The FDA product code for EmbryoScope+ is MQG.

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。

K213869EmbryoSlide+ ic8 dish K182798KIDScore D3

相关器械（代码：MQG）

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。

K261083华莱士® 吸引泵（WAPV1）；华莱士® 泵过滤器连接器（WFC）；华莱士® 真空连接套件（WVCK）CooperSurgical, Inc.K260194真空泵（型号：AD-VPUM-500）Sheng Sheng Yi (Beijing) Technology Company Limited K242684Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd.K232493Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)Wuhan Huchuang Union Technology Co., Ltd.K180188Geri 胚胎孵化器，配备 Geri Connect 和 Geri 评估软件，以及 Geri 碗Genea Biomedx Pty, Ltd.K180304Geri 胚胎孵化器和 Geri 碗Genea Biomedx Pty, Ltd.

官方来源

在 FDA 数据库中查看 →

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。