Cleared Traditional

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

K180188 · Genea Biomedx Pty, Ltd. · Obstetrics & Gynecology
Jun 2018
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K180188 is an FDA 510(k) clearance for the Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish, a Accessory, Assisted Reproduction (Class II — Special Controls, product code MQG), submitted by Genea Biomedx Pty, Ltd. (Sydney, AU). The FDA issued a Cleared decision on June 7, 2018, 135 days after receiving the submission on January 23, 2018. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6120.

Submission Details

510(k) Number K180188 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2018
Decision Date June 07, 2018
Days to Decision 135 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MQG — Accessory, Assisted Reproduction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6120

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