COROMETRICS MODEL 120 SERIES MATERNAL/FETAL MONITOR W/INTEGRATED FETAL PULSE OXIMETRY
FDA premarket approval P000016/S001 · decided 2001-11-09
Approval details
- PMA number
- P000016
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COROMETRICS MODEL 120 SERIES MATERNAL/FETAL MONITOR W/INTEGRATED FETAL PULSE OXIMETRY
- Generic name
- Oximeter, fetal pulse
- Applicant
- Ge Medical Systems Information Technologies
- Date received
- 2001-05-21
- Decision date
- 2001-11-09
- Days to decision
- 172 days
- Decision code
- APPR
- Product code
- MMA
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Laurel, MD
- Statement
- APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT WIPRO GE MEDICAL SYSTEMS, BANGALORE, INDIA.
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