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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
ApplicantNELLCOR PURITAN BENNETT, INC.
PMA NumberP990053
Supplement NumberS007
Date Received04/05/2002
Decision Date04/18/2002
Product Code
MMA
Advisory Committee Obstetrics/Gynecology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the manufacturing site for the fetal sensor emitter, a component of the oxifirst fetal sensor. The sensor emitter will be manufactured at the tyco facility in insurgentes, tijuana, mexico, where the fetal sensors are manufactured.
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