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| Device | SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING |
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| Generic Name | Oximeter, fetal pulse |
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| Applicant | PHILIPS MEDICAL SYSTEMS, INC.
3000 MINUTEMAN RD. MS 0491
ANDOVER, MA 01810-1099 |
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| PMA Number | P020028 |
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| Date Received | 07/09/2002 |
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| Decision Date | 01/03/2003 |
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Withdrawal Date
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01/22/2010 |
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| Product Code |
MMA |
| Docket Number | 03M-0241 |
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| Notice Date | 06/25/2003 |
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| Advisory Committee |
Obstetrics/Gynecology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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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 |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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