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FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Assisted Reproduction Devices
CFR Sub-Part
MQE
Needle, Assisted Reproduction
2
Product Code
MQF
Catheter, Assisted Reproduction
2
Product Code
MQG
Accessory, Assisted Reproduction
2
Product Code
K
18
0188
Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish
2
Cleared 510(K)
K
17
3264
EmbryoScope+
2
Cleared 510(K)
K
18
0304
Geri Embryo Incubator and Geri Dish
2
Cleared 510(K)
K
17
1736
Geri Embryo Incubator and Geri Dish
2
Cleared 510(K)
K
16
0753
COOK Vacuum Pump
2
Cleared 510(K)
K
16
0504
RI Witness Embryology Heated Plate
2
Cleared 510(K)
K
15
1357
MIRI TL
2
Cleared 510(K)
K
13
3712
EMBRYOVIEWER SOFTWARE
2
Cleared 510(K)
K
13
2870
Origio Gas Line Filter
2
Cleared 510(K)
K
13
3742
XQ-1 INCUBATOR
2
Cleared 510(K)
Show All 43 Submissions
MQH
Microtools, Assisted Reproduction (Pipettes)
2
Product Code
MQI
Microtool Fabrication, Assisted Reproduction
2
Product Code
MQJ
Micromanipulators And Microinjectors, Assisted Reproduction
2
Product Code
MQK
Labware, Assisted Reproduction
2
Product Code
MQL
Media, Reproductive
2
Product Code
MRX
System, Assisted Reproduction Laser
2
Product Code
MTW
System, Water, Reproduction, Assisted, And Purification
2
Product Code
MTX
Microscope And Microscope Accessories, Reproduction, Assisted
1
Product Code
NNB
Needle, Reproduction, Assisted, Reprocessed
2
Product Code
PBH
Embryo Image Assessment System, Assisted Reproduction
2
Product Code
OYO
Culture, Intravaginal, Assisted Reproduction
2
Product Code
PUB
Accessory, Assisted Reproduction, Exempt
2
Product Code
PUC
Microtools, Assisted Reproduction (Pipettes), Exempt
2
Product Code
PUD
Labware, Assisted Reproduction, Exempt
2
Product Code
QKH
Assisted Reproduction Laminar Flow Workstation
2
Product Code
QKI
Media, Reproductive, Exempt
2
Product Code
Cardiovascular Monitoring Devices
CFR Sub-Part
Cardiovascular Prosthetic Devices
CFR Sub-Part
Clinical Chemistry Test Systems
CFR Sub-Part
Diagnostic Devices
CFR Sub-Part
Miscellaneous
Miscellaneous
Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Obstetrical and Gynecological Prosthetic Devices
CFR Sub-Part
Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Obstetrical and Gynecological Therapeutic Devices
CFR Sub-Part
Physical Medicine Prosthetic Devices
CFR Sub-Part
Prosthetic Devices
CFR Sub-Part
Therapeutic Devices
CFR Sub-Part
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 2 June 2023 at 11:04 pm
OB
/
assisted-reproduction-devices
/
MQG
/
K180304
View Source
Geri Embryo Incubator and Geri Dish
Page Type
Cleared 510(K)
PDF
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
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Assisted Reproduction Devices
MQE
Needle, Assisted Reproduction
MQF
Catheter, Assisted Reproduction
MQG
Accessory, Assisted Reproduction
K
18
0188
Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish
K
17
3264
EmbryoScope+
K
18
0304
Geri Embryo Incubator and Geri Dish
K
17
1736
Geri Embryo Incubator and Geri Dish
K
16
0753
COOK Vacuum Pump
K
16
0504
RI Witness Embryology Heated Plate
K
15
1357
MIRI TL
K
13
3712
EMBRYOVIEWER SOFTWARE
K
13
2870
Origio Gas Line Filter
K
13
3742
XQ-1 INCUBATOR
Show All 43 Submissions
MQH
Microtools, Assisted Reproduction (Pipettes)
MQI
Microtool Fabrication, Assisted Reproduction
MQJ
Micromanipulators And Microinjectors, Assisted Reproduction
MQK
Labware, Assisted Reproduction
MQL
Media, Reproductive
MRX
System, Assisted Reproduction Laser
MTW
System, Water, Reproduction, Assisted, And Purification
MTX
Microscope And Microscope Accessories, Reproduction, Assisted
NNB
Needle, Reproduction, Assisted, Reprocessed
PBH
Embryo Image Assessment System, Assisted Reproduction
OYO
Culture, Intravaginal, Assisted Reproduction
PUB
Accessory, Assisted Reproduction, Exempt
PUC
Microtools, Assisted Reproduction (Pipettes), Exempt
PUD
Labware, Assisted Reproduction, Exempt
QKH
Assisted Reproduction Laminar Flow Workstation
QKI
Media, Reproductive, Exempt
Cardiovascular Monitoring Devices
Cardiovascular Prosthetic Devices
Clinical Chemistry Test Systems
Diagnostic Devices
Miscellaneous
Obstetrical and Gynecological Diagnostic Devices
Obstetrical and Gynecological Monitoring Devices
Obstetrical and Gynecological Prosthetic Devices
Obstetrical and Gynecological Surgical Devices
Obstetrical and Gynecological Therapeutic Devices
Physical Medicine Prosthetic Devices
Prosthetic Devices
Therapeutic Devices
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OB
/
assisted-reproduction-devices
/
MQG
/
K180304
View Source
Geri Embryo Incubator and Geri Dish
Page Type
Cleared 510(K)
PDF
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