FDA 510(k)

Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish

Numéro K : K180188 · 2018-06-07

Date de décision2018-06-07

Code produitMQG

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

Geri Embryo Incubator with Geri Connect and Geri Assess Software, 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 2018-06-07 under 510(k) number K180188. The device is classified under product code MQG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish?

Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish is a medical device that received FDA 510(k) clearance on 2018-06-07. The listed applicant is Genea Biomedx Pty, Ltd.. The 510(k) number is K180188.

When did Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish receive FDA 510(k) clearance?

Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish received FDA 510(k) clearance on 2018-06-07, under 510(k) number K180188.

Who is the listed applicant for Geri Embryo Incubator with Geri Connect and Geri Assess Software, 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 with Geri Connect and Geri Assess Software, and Geri Dish?

The FDA product code for Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish is MQG.

Essais cliniques associés

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Autres dossiers indiquant Genea Biomedx Pty, Ltd. en tant que demandeur

K180304Geri Embryo Incubator and Geri Dish K171736Geri 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

Dispositifs connexes (Code : 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.K173264EmbryoScope+Vitrolife A/S K180304Geri Embryo Incubator and Geri DishGenea Biomedx Pty, Ltd.

Source officielle

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