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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 Namefetal pulse oximeter
ApplicantCOVIDIEN, FORMERLY NELLCOR 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 location change: manufacturer
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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