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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceCOROMETRICS 120F SERIES MATERNAL/FETAL MONITOR
Classification Nameoximeter, fetal pulse
Generic Nameoximeter, fetal pulse
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8880 gorman road
laurel, MD 20723
PMA NumberP000016
Date Received04/05/2000
Decision Date02/09/2001
Withdrawal Date 09/12/2007
Product Code
MMA
Docket Number 01M-0329
Notice Date 08/02/2001
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITN INTEGRATED FETAL OXYGEN SATURATION MONITORING, COROMETRICS FETAL PATIENT MOFULE, AND THE NELLCOR OXIFIRST(TM) FS14 SENSOR. THE 120 F-SERIES SYSTEM CONTINUOUSLY MONITORS INTRAPARTUM FETAL OXYGEN SATURATION (FSPO2) AND IS INDICATED AS AN ADJUNCT TO FETAL HEART RATE (FHR) MONITORING IN THE PRESENCE OF A NONREASSURING FETAL HEART RATE PATTERN. IT SHOULD ONLY BE USED AFTER MATERNAL MEMBRANES HAVE RUPTURED AND ON A SINGLETON FETUS IN VERTEX PRESENTATION WITH A GESTATIONAL AGE GREATER THAN OR EQUAL TO 36 WEEKS.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 
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