- Device
- COROMETRICS MODEL 120 SERIES MATERNAL/FETAL MONITOR W/INTEGRATED FETAL PULSE OXIMETRY
- Applicant
- Ge Medical Systems Information Technologies
- PMA number
- P000016
- Supplement
- S001
- Product code
- MMA
- Generic name
- Oximeter, fetal pulse
- Decision date
- 2001-11-09
- Decision code
- APPR
- Date received
- 2001-05-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT WIPRO GE MEDICAL SYSTEMS, BANGALORE, INDIA.