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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 NameCOROMETRICS MODEL 120 SERIES MATERNAL/FETAL MONITOR W/INTEGRATED FETAL PULSE OXIMETRY
Classification Nameoximeter, fetal pulse
Generic Namefetal pulse oximeter
ApplicantGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
PMA NumberP000016
Supplement NumberS001
Date Received05/21/2001
Decision Date11/09/2001
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 a manufacturing facility located at wipro ge medical systems, bangalore, india.
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