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FDA 510(k)

Geri Embryo Incubator and Geri Dish

K-Number: K180304 · 2018-04-20

ApplicantGenea Biomedx Pty, Ltd.
Decision Date2018-04-20
Product CodeMQG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Geri Embryo Incubator and Geri Dish is a medical device manufactured by Genea Biomedx Pty, Ltd.. It received FDA 510(k) clearance on 2018-04-20 under approval number K180304. The device is classified under product code MQG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Genea Biomedx Pty, Ltd.. The 510(k) number is K180304.

When was Geri Embryo Incubator and Geri Dish approved by the FDA?

Geri Embryo Incubator and Geri Dish received FDA 510(k) clearance on 2018-04-20, under approval number K180304.

What company makes Geri Embryo Incubator and Geri Dish?

Geri Embryo Incubator and Geri Dish is manufactured by Genea Biomedx Pty, Ltd..

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.

Related Clinical Trials

NCT07270250 Impact of Dry vs Humidified Culture Conditions on Blastocyst Development and Aneuploidy: A Time-lapse Sibling Oocyte Study RECRUITING NCT07522281 Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles NOT_YET_RECRUITING

Other Devices by Genea Biomedx Pty, Ltd.

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 K180188Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish

Related Devices (Code: MQG)

K160504RI Witness Embryology Heated PlateResearch Instruments Limited K151357MIRI TLAt Medical Uab K171736Geri Embryo Incubator and Geri DishGenea Biomedx Pty, Ltd. K160753COOK Vacuum PumpWilliam A. Cook Australia Pty. , Ltd. K180188Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri DishGenea Biomedx Pty, Ltd. K173264EmbryoScope+Vitrolife A/S

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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