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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.
 
Trade NameCOROMETRICS 120F SERIES MATERNAL/FETAL MONITOR
Classification Nameoximeter, fetal pulse
Generic Namefetal pulse oximeter
ApplicantGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 
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