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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
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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