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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA 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
ApplicantCOVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.
PMA NumberP990053
Supplement NumberS010
Date Received10/17/2002
Decision Date11/15/2002
Product Code
MMA
Advisory Committee Obstetrics/Gynecology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the labeling.
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