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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameOXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
Classification Nameoximeter, fetal pulse
Generic Namefetal pulse oximeter
ApplicantNELLCOR PURITAN BENNETT, INC.
PMA NumberP990053
Date Received09/21/1999
Decision Date05/12/2000
Product Code
MMA
Docket Number 00M-1448
Notice Date 08/24/2000
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the nellcor n-400 fetal oxygen saturation monitoring system (oxifirst(tm) system).
Approval Order Approval Order
Supplements: S001 S002 S003 S005 S006 S007 
S008 S009 S010 S011 S012 
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