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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceOXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
Generic NameOximeter, fetal pulse
ApplicantCovidien, LLC
6135 Gunbarrel Avenue
Boulder, CO 80301
PMA NumberP990053
Date Received09/21/1999
Decision Date05/12/2000
Withdrawal Date 06/02/2017
Product Code MMA 
Docket Number 00M-1448
Notice Date 08/24/2000
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE NELLCOR N-400 FETAL OXYGEN SATURATION MONITORING SYSTEM (OXIFIRST(TM) SYSTEM).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S005 S006 S007 S008 S009 S010 S011 S012 
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