Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- Assisted Reproduction DevicesCFR Sub-Part
- MQENeedle, Assisted Reproduction2Product Code
- MQFCatheter, Assisted Reproduction2Product Code
- MQGAccessory, Assisted Reproduction2Product Code
- K180188Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish2Cleared 510(K)
- K173264EmbryoScope+2Cleared 510(K)
- K180304Geri Embryo Incubator and Geri Dish2Cleared 510(K)
- K171736Geri Embryo Incubator and Geri Dish2Cleared 510(K)
- K160753COOK Vacuum Pump2Cleared 510(K)
- K160504RI Witness Embryology Heated Plate2Cleared 510(K)
- K151357MIRI TL2Cleared 510(K)
- K133712EMBRYOVIEWER SOFTWARE2Cleared 510(K)
- K132870Origio Gas Line Filter2Cleared 510(K)
- K133742XQ-1 INCUBATOR2Cleared 510(K)
- Show All 43 Submissions
- MQHMicrotools, Assisted Reproduction (Pipettes)2Product Code
- MQIMicrotool Fabrication, Assisted Reproduction2Product Code
- MQJMicromanipulators And Microinjectors, Assisted Reproduction2Product Code
- MQKLabware, Assisted Reproduction2Product Code
- MQLMedia, Reproductive2Product Code
- MRXSystem, Assisted Reproduction Laser2Product Code
- MTWSystem, Water, Reproduction, Assisted, And Purification2Product Code
- MTXMicroscope And Microscope Accessories, Reproduction, Assisted1Product Code
- NNBNeedle, Reproduction, Assisted, Reprocessed2Product Code
- PBHEmbryo Image Assessment System, Assisted Reproduction2Product Code
- OYOCulture, Intravaginal, Assisted Reproduction2Product Code
- PUBAccessory, Assisted Reproduction, Exempt2Product Code
- PUCMicrotools, Assisted Reproduction (Pipettes), Exempt2Product Code
- PUDLabware, Assisted Reproduction, Exempt2Product Code
- QKHAssisted Reproduction Laminar Flow Workstation2Product Code
- QKIMedia, Reproductive, Exempt2Product Code
- Cardiovascular Monitoring DevicesCFR Sub-Part
- Cardiovascular Prosthetic DevicesCFR Sub-Part
- Clinical Chemistry Test SystemsCFR Sub-Part
- Diagnostic DevicesCFR Sub-Part
- MiscellaneousMiscellaneous
- Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- Physical Medicine Prosthetic DevicesCFR Sub-Part
- Prosthetic DevicesCFR Sub-Part
- Therapeutic DevicesCFR Sub-Part
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Geri Embryo Incubator and Geri Dish
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K180304
- 510(k) Type
- Special
- Applicant
- Genea Biomedx Pty Ltd
- Country
- Australia
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/20/2018
- Days to Decision
- 77 days
- Submission Type
- Summary