OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
FDA premarket approval P990053 · decided 2000-05-12
Approval details
- PMA number
- P990053
- Trade name
- OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
- Generic name
- Oximeter, fetal pulse
- Applicant
- Covidien, LLC
- Date received
- 1999-09-21
- Decision date
- 2000-05-12
- Days to decision
- 234 days
- Decision code
- APWD
- Product code
- MMA
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Boulder, CO
- Statement
- APPROVAL FOR THE NELLCOR N-400 FETAL OXYGEN SATURATION MONITORING SYSTEM (OXIFIRST(TM) SYSTEM).
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