Geri Embryo Incubator and Geri Dish— 510(k) K171736
Substantially EquivalentGenea Biomedx Pty, Ltd.
FDA 510(k) clearance K171736 for Geri Embryo Incubator and Geri Dish, Substantially Equivalent on 2017-11-15. Applicant: Genea Biomedx Pty, Ltd.. Device class: 2.
Clearance details
- Applicant
- Genea Biomedx Pty, Ltd.
- Product code
- Code MQG
- Device class
- Class 2
- Regulation
- 21 CFR 884.6120
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sydney, AU
Recent devices under product code MQG
view all- K261083 — Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)
- K260194 — Vacuum Pump (Model: AD-VPUM-500)
- K242684 — Harioculture TL-16 Time-lapse Incubator
- K232493 — Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)
- K180188 — Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish
More clearances from Genea Biomedx Pty, Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.