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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(TM) FETAL SENSOR FS14-SERIES
Classification Nameoximeter, fetal pulse
Generic Nameoximeter, fetal pulse
ApplicantNELLCOR PURITAN BENNETT, INC.
PMA NumberP990053
Supplement NumberS002
Date Received06/05/2001
Decision Date12/19/2001
Product Code
MMA
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate manufacturing facility located at tyco healthcare group, tijuana, mexico.
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