Geri Embryo Incubator and Geri Dish— 510(k) K180304

Substantially Equivalent

Genea Biomedx Pty, Ltd.

FDA 510(k) clearance K180304 for Geri Embryo Incubator and Geri Dish, Substantially Equivalent on 2018-04-20. Applicant: Genea Biomedx Pty, Ltd..

Clearance details

Applicant: Genea Biomedx Pty, Ltd.
Product code: Code MQG
Advisory panel: Obstetrics/Gynecology
Date received: 2018-02-02
Decision date: 2018-04-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Sydney, AU

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