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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.
 
DeviceCOROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITH INTERGRATED FETAL OXYGEN SATURATION MONITORING
Classification Nameoximeter, fetal pulse
Generic Nameoximeter, fetal pulse
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8880 gorman road
laurel, MD 20723
PMA NumberP000016
Supplement NumberS002
Date Received09/15/2003
Decision Date10/15/2003
Product Code
MMA
Advisory Committee Obstetrics/Gynecology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the labeling.
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