COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITH INTERGRATED FETAL OXYGEN SATURATION MONITORING
FDA premarket approval P000016/S002 · decided 2003-10-15
Approval details
- PMA number
- P000016
- Supplement
- S002
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- 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
- Date received
- 2003-09-15
- Decision date
- 2003-10-15
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MMA
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Laurel, MD
- Statement
- APPROVAL FOR MODIFICATIONS TO THE LABELING.
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