Geri Embryo Incubator and Geri Dish— 510(k) K171736

Substantially Equivalent

Genea Biomedx Pty, Ltd.

FDA 510(k) clearance K171736 for Geri Embryo Incubator and Geri Dish, Substantially Equivalent on 2017-11-15. Applicant: Genea Biomedx Pty, Ltd..

Clearance details

Applicant: Genea Biomedx Pty, Ltd.
Product code: Code MQG
Advisory panel: Obstetrics/Gynecology
Date received: 2017-06-12
Decision date: 2017-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sydney, AU

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