510(k) K180188
K180188 is an FDA 510(k) premarket notification submitted by Genea Biomedx Pty, Ltd. for the device "Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish". The FDA issued a decision of Substantially Equivalent on June 7, 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
- June 7, 2018
- Date Received
- January 23, 2018
- Clearance Type
- Traditional
- 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