PMA P990053S001
- Device
- OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
- Applicant
- Covidien, LLC
- PMA number
- P990053
- Supplement
- S001
- Product code
- MMA
- Decision date
- 2001-10-05
- Classification
- Oximeter, Fetal Pulse
- Generic name
- Oximeter, fetal pulse
- Approval order statement
- APPROVAL FOR CHANGES TO THE POST APPROVAL STUDY PLAN.
Current openFDA PMA Record#
- Device
- OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
- Applicant
- Covidien, LLC
- PMA number
- P990053
- Supplement
- S001
- Product code
- MMA
- Generic name
- Oximeter, fetal pulse
- Decision date
- 2001-10-05
- Decision code
- APPR
- Date received
- 2001-04-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL FOR CHANGES TO THE POST APPROVAL STUDY PLAN.