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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceSERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING
Classification Nameoximeter, fetal pulse
Generic Nameoximeter, fetal pulse
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
3000 minuteman rd. ms 0491
andover, MA 01810-1099
PMA NumberP020028
Date Received07/09/2002
Decision Date01/03/2003
Withdrawal Date 01/22/2010
Product Code
MMA
Docket Number 03M-0241
Notice Date 06/25/2003
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the series 50 xmo (model m1350c) fetal/maternal monitor system with integrated fetal oxygen saturation monitoring, m1365a fetal spo2 patient module, and the nellcor oxifirst fs14 sensor. This device is intended for continuous monitoring of intrapartum fetal oxygen saturation (fspo2) and the fspo2 parameter 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 amniotic 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
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