Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish— 510(k) K180188

Substantially Equivalent

Genea Biomedx Pty, Ltd.

FDA 510(k) clearance K180188 for Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish, Substantially Equivalent on 2018-06-07. Applicant: Genea Biomedx Pty, Ltd..

Clearance details

Applicant: Genea Biomedx Pty, Ltd.
Product code: Code MQG
Advisory panel: Obstetrics/Gynecology
Date received: 2018-01-23
Decision date: 2018-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sydney, AU

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