This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the nellcor n-400 fetal oxygen saturation monitoring system (oxifirst(tm) system).
| Device | OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM |
| Classification Name | Oximeter, Fetal Pulse |
| Generic Name | Oximeter, Fetal Pulse |
| Applicant | Covidien, LLC |
| Date Received | 1999-09-21 |
| Decision Date | 2000-05-12 |
| Notice Date | 2000-08-24 |
| PMA | P990053 |
| Supplement | S |
| Product Code | MMA |
| Docket Number | 00M-1448 |
| Advisory Committee | Obstetrics/Gynecology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Covidien, LLC 6135 Gunbarrel Avenue boulder, CO 80301 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990053 | Original Filing | |
| S012 | 2005-03-04 | 135 Review Track For 30-day Notice |
| S011 | 2004-11-22 | 135 Review Track For 30-day Notice |
| S010 | 2002-10-17 | Special (immediate Track) |
| S009 | 2002-04-17 | Normal 180 Day Track |
| S008 | 2002-04-16 | Normal 180 Day Track |
| S007 | 2002-04-05 | 30-day Notice |
| S006 | 2002-03-26 | Normal 180 Day Track |
| S005 | 2001-12-31 | Normal 180 Day Track |
| S004 | ||
| S003 | 2001-10-12 | 30-day Notice |
| S002 | 2001-06-05 | Normal 180 Day Track |
| S001 | 2001-04-09 | Normal 180 Day Track |