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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 NameOXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
Classification Nameoximeter, fetal pulse
Generic Namefetal pulse oximeter
ApplicantCOVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.
PMA NumberP990053
Supplement NumberS009
Date Received04/17/2002
Decision Date11/25/2002
Product Code
MMA
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new manufacturing facility located at nellcor puritan bennett, inc. , minneapolis, minnesota. This facility will perform manufacturing of the fsp02-pm fetal patient modules.
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