Note: 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. |
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Device | OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM |
Generic Name | Oximeter, fetal pulse |
Applicant | Covidien, LLC 6135 Gunbarrel Avenue Boulder, CO 80301 |
PMA Number | P990053 |
Date Received | 09/21/1999 |
Decision Date | 05/12/2000 |
Withdrawal Date
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06/02/2017 |
Product Code |
MMA |
Docket Number | 00M-1448 |
Notice Date | 08/24/2000 |
Advisory Committee |
Obstetrics/Gynecology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE NELLCOR N-400 FETAL OXYGEN SATURATION MONITORING SYSTEM (OXIFIRST(TM) SYSTEM). |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S005 S006 S007 S008 S009 S010 S011 S012
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