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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 NumberS003
Date Received10/12/2001
Decision Date11/09/2001
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 sterilization process by eliminating the post sterilization visual inspection for the oxyfirst fetal sensor fs14-series. Also, a change in the site of final product distribution from the present facility in carlsbad, california to a tyco distribution facility in atlanta, georgia.
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