510(k) K180304
K180304 is an FDA 510(k) premarket notification submitted by Genea Biomedx Pty, Ltd. for the device "Geri Embryo Incubator and Geri Dish". The FDA issued a decision of Substantially Equivalent on April 20, 2018. The device falls under product code MQG (Accessory, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6120. Genea Biomedx Pty, Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 2018
- Date Received
- February 2, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessory, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6120
- Review Panel
- OB
- Submission Type