PMA P990053S011
- Device
- OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
- Applicant
- Covidien, LLC
- PMA number
- P990053
- Supplement
- S011
- Product code
- MMA
- Decision date
- 2005-02-25
- Classification
- Oximeter, Fetal Pulse
- Generic name
- Oximeter, fetal pulse
- Approval order statement
- APPROVAL FOR THE QUALIFICATION OF AN ADDITIONAL SUPPLIER FOR THE TWO LIGHT EMITTING DIODES WITHIN THE OXIMETRY SENSOR.
Current openFDA PMA Record#
- Device
- OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
- Applicant
- Covidien, LLC
- PMA number
- P990053
- Supplement
- S011
- Product code
- MMA
- Generic name
- Oximeter, fetal pulse
- Decision date
- 2005-02-25
- Decision code
- APPR
- Date received
- 2004-11-22
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE QUALIFICATION OF AN ADDITIONAL SUPPLIER FOR THE TWO LIGHT EMITTING DIODES WITHIN THE OXIMETRY SENSOR.