FDA 510(k)

Geri Embryo Incubator and Geri Dish

Número K: K171736 · 2017-11-15

Data da decisão2017-11-15

Código do produtoMQG

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

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 2017-11-15 under 510(k) number K171736. The device is classified under product code MQG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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 2017-11-15. The listed applicant is Genea Biomedx Pty, Ltd.. The 510(k) number is K171736.

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 2017-11-15, under 510(k) number K171736.

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.

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Outros registros que listam Genea Biomedx Pty, Ltd. como candidato(a)

K180188Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish K180304Geri Embryo Incubator and Geri Dish K170498Gems Oocyte Retrieval Buffer ORB-20, ORB-50 K162409Gems Vitrification Set, Gems Warming Set K161261Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase

Dispositivos Relacionados (Código: MQG)

K261083Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)CooperSurgical, Inc.K260194Vacuum Pump (Model: 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 Embryo Incubator with Geri Connect and Geri Assess Software, and Geri DishGenea Biomedx Pty, Ltd.K173264EmbryoScope+Vitrolife A/S

Fonte oficial

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