FDA 510(k)

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

N.º K: K180188 · 2018-06-07

Fecha de decisión2018-06-07

Código de productoMQG

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Genea Biomedx Pty, Ltd. como solicitante

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

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.K173264EmbryoScope+Vitrolife A/S K180304Geri Embryo Incubator and Geri DishGenea Biomedx Pty, Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.