Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish— 510(k) K180188
Substantially EquivalentGenea Biomedx Pty, Ltd.
FDA 510(k) clearance K180188 for Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish, Substantially Equivalent on 2018-06-07. 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
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- K242684 — Harioculture TL-16 Time-lapse Incubator
- K232493 — Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)
- K173264 — EmbryoScope+
More clearances from Genea Biomedx Pty, Ltd.
view all- K180304 — Geri Embryo Incubator and Geri Dish
- K171736 — Geri Embryo Incubator and Geri Dish
- K170498 — Gems Oocyte Retrieval Buffer ORB-20, ORB-50
- K162409 — Gems Vitrification Set, Gems Warming Set
- K161261 — Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase
Data sourced from openFDA. This site is unofficial and independent of the FDA.