PMA P000016
- Device
- COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITH INTERGRATED FETAL OXYGEN SATURATION MONITORING
- Applicant
- Ge Medical Systems Information Technologies
- PMA number
- P000016
- Supplement
- S002
- Product code
- MMA
- Decision date
- 2003-10-15
- Classification
- Obstetrics/Gynecology
- Generic name
- Oximeter, fetal pulse
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE LABELING.
Current openFDA PMA Record#
- Device
- COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITH INTERGRATED FETAL OXYGEN SATURATION MONITORING
- Applicant
- Ge Medical Systems Information Technologies
- PMA number
- P000016
- Supplement
- S002
- Product code
- MMA
- Generic name
- Oximeter, fetal pulse
- Decision date
- 2003-10-15
- Decision code
- APPR
- Date received
- 2003-09-15
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE LABELING.