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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 NumberS006
Date Received03/26/2002
Decision Date01/07/2003
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 an alternate manufacturing site for the n-400 fetal pulse oximeter. The manufacturing site is located at nellcor puritan bennett ireland, galway, ireland.
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