Geri 胚胎孵化器和 Geri 碗
K号: K180304 · 2018-04-20
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决定日期2018-04-20
产品代码MQG
咨询委员会OB
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决定实质等同
器械摘要
Geri Embryo Incubator and Geri Dish is the device name listed in this FDA 510(k) record. The listed applicant is Genea Biomedx Pty, Ltd.. It received FDA 510(k) clearance on 2018-04-20 under 510(k) number K180304. 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 Geri Embryo Incubator and Geri Dish?
Geri Embryo Incubator and Geri Dish is a medical device that received FDA 510(k) clearance on 2018-04-20. The listed applicant is Genea Biomedx Pty, Ltd.. The 510(k) number is K180304.
When did Geri Embryo Incubator and Geri Dish receive FDA 510(k) clearance?
Geri Embryo Incubator and Geri Dish received FDA 510(k) clearance on 2018-04-20, under 510(k) number K180304.
Who is the listed applicant for Geri Embryo Incubator and Geri Dish?
The FDA 510(k) record lists Genea Biomedx Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Geri Embryo Incubator and Geri Dish?
The FDA product code for Geri Embryo Incubator and Geri Dish is MQG.
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Genea Biomedx Pty, Ltd.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：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 LimitedK242684Harioculture 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.K173264EmbryoScope+Vitrolife A/S
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。
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