PMA P990053S005
- Device
- OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
- Applicant
- Covidien, LLC
- PMA number
- P990053
- Supplement
- S005
- Product code
- MMA
- Decision date
- 2002-06-28
- Classification
- Oximeter, Fetal Pulse
- Generic name
- Oximeter, fetal pulse
- Approval order statement
- APPROVAL FOR SOFTWARE UPGRADE.
Current openFDA PMA Record#
- Device
- OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
- Applicant
- Covidien, LLC
- PMA number
- P990053
- Supplement
- S005
- Product code
- MMA
- Generic name
- Oximeter, fetal pulse
- Decision date
- 2002-06-28
- Decision code
- APPR
- Date received
- 2001-12-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SOFTWARE UPGRADE.