Clearance Summary
Geri Embryo Incubator and Geri Dish received FDA 510(k) clearance under submission number K180304, sponsored by Genea Biomedx Pty, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2018-04-20.
- Submission: K180304
- Applicant / Sponsor: Genea Biomedx Pty, Ltd.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6120
- Decision date: 2018-04-20
Classification & Regulation
This clearance is catalogued under FDA product code MQG and 21 CFR 884.6120, within the Obstetrics/Gynecology review panel as a Class II device.