|
Device | COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITH INTERGRATED FETAL OXYGEN SATURATION MONITORING |
Generic Name | Oximeter, fetal pulse |
Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8880 GORMAN ROAD LAUREL, MD 20723 |
PMA Number | P000016 |
Supplement Number | S002 |
Date Received | 09/15/2003 |
Decision Date | 10/15/2003 |
Withdrawal Date
|
09/12/2007 |
Product Code |
MMA |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE LABELING. |