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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 NumberS011
Date Received11/22/2004
Decision Date02/25/2005
Product Code
MMA
Advisory Committee Obstetrics/Gynecology
Supplement Type135 review track for 30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the qualification of an additional supplier for the two light emitting diodes within the oximetry sensor.
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