510(k) K180188
- Device
- Geri Embryo Incubator With Geri Connect And Geri Assess Software, And Geri Dish
- Applicant
- Genea Biomedx Pty Ltd
- 510(k) number
- K180188
- Product code
- MQG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-06-07
- Date received
- 2018-01-23
- Regulation
- 884.6120
- Classification name
- Accessory, Assisted Reproduction
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kea Dent
- Address
- Level 2, 321 Kent St. Sydney AU 2000 2000
FDA Registration Numbers#
- 3004871219
- 1000393132
- 1222779
- 3009747883
- 9680654
- 1523845
- 1216677
- 9617472
- 3034431159
- 3023235140
- 3009107689
- 3003244268
- 3012853704
- 1820334
- 1221433
- 3017247483
- 3008157119
- 9610632
- 3006405073
- 3005580113
- 3003775072
- 1825146
- 9613662
- 1066270
Source Documents#
Other 510(k) Records For Product Code MQG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260194 | Vacuum Pump (Model: AD-VPUM-500) | Sheng Sheng Yi (Beijing) Technology Company Limited | 2026-04-28 |
| K242684 | Harioculture TL-16 Time-lapse Incubator | Hua Yue Medical Technology Co., Ltd. | 2025-05-22 |
| K232493 | Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) | Wuhan Huchuang Union Technology Co., Ltd. | 2024-05-07 |
| K173264 | EmbryoScope+ | Vitrolife A/S | 2018-05-11 |
| K180304 | Geri Embryo Incubator and Geri Dish | Genea Biomedx Pty, Ltd. | 2018-04-20 |
| K171736 | Geri Embryo Incubator and Geri Dish | Genea Biomedx Pty, Ltd. | 2017-11-15 |
| K160753 | COOK Vacuum Pump | William A. Cook Australia Pty. , Ltd. | 2017-06-13 |
| K160504 | RI Witness Embryology Heated Plate | Research Instruments Limited | 2016-07-18 |
| K151357 | MIRI TL | At Medical Uab | 2016-04-22 |
| K133712 | EMBRYOVIEWER SOFTWARE | Unisense Fertilitech A/S | 2014-08-08 |
| K132870 | Origio Gas Line Filter | Origio, Inc. | 2014-05-07 |
| K133742 | XQ-1 INCUBATOR | At Medical Uab | 2014-04-23 |
| K121566 | PLANER BT37 INCUBATOR | Planer Plc | 2012-11-29 |
| K113075 | EMBRYO VIEWER SOFTWARE | Unisense Fertilitech A/S | 2011-12-21 |
| K111715 | EMBRYOSCOPE | Unisense Fertilitech A/S | 2011-08-11 |
Legacy Summary#
summary
FDA Review#
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