PMA P990053S010
- Device
- OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
- Applicant
- Covidien, LLC
- PMA number
- P990053
- Supplement
- S010
- Product code
- MMA
- Decision date
- 2002-11-15
- Classification
- Oximeter, Fetal Pulse
- Generic name
- Oximeter, fetal pulse
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE LABELING.
Current openFDA PMA Record#
- Device
- OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
- Applicant
- Covidien, LLC
- PMA number
- P990053
- Supplement
- S010
- Product code
- MMA
- Generic name
- Oximeter, fetal pulse
- Decision date
- 2002-11-15
- Decision code
- APPR
- Date received
- 2002-10-17
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE LABELING.